CSL Plasma jobs in National City, CA - 23 jobs

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Senior Operations Management Trainee (Senior OMT) About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. Equal Employment Opportunity Are you a senior leader interested in bringing your expertise to a place where you can feel good about the work you do? Do you want to develop new skills and set yourself up for continued growth? As a Senior Operations Management Trainee at BioLife, you will participate in an advanced leadership development program that will take you to our plasma centers across the country. You'll travel up to 95% of the time to learn the business while networking with supportive leaders and prepare yourself for accelerated career growth. Our growth is your bright future. Opportunities to grow as a leader are within your reach. With the incredible growth of 220+ BioLife Plasma Services centers across the U.S., the future looks bright for you. When you work at BioLife, you'll feel good knowing what you do makes a difference. A typical day for you may include: Continuous Learning & Development: The expedited training program lasts approximately six months. Upon completion, you'll have 12 months to obtain a Plasma Center Manager position. During this time, you'll receive hands-on experience and have mentorship opportunities. Drive your own learning plan that covers all aspects of managing our high-volume blood plasma collection facilities. Team Management: You'll use your interpersonal and communication skills to cultivate a positive environment and motivate a team of diverse individuals. Provide employee feedback, conduct performance reviews, support team members' development, participate in staff planning and recruiting, and engage and retain employees. Career Advancement: Work towards obtaining a Plasma Center Operations Manager position by completing the training program, networking, and building relationships across BioLife. As you progress your career at BioLife, you'll have opportunities to open and operate brand new plasma centers. Supportive Teamwork: You'll work in our fast-paced, team environment; provide operational support; conduct management training; problem-solve; and communicate with senior management. Exceptional Customer Service: Retain donors by creating a positive donor experience. You may also assist with production. Travel Opportunities: Learn from and network with BioLife team members across the country. You'll be able to return home every other weekend. REQUIRED QUALIFICATIONS: 3-5 years of experience leading medium to large teams (20+ direct reports) Up to 90-100% travel during the Trainee Program Ability to walk and/or stand for the entire work shift Willingness to travel and work at various BioLife locations across the country Ability to work evenings, weekends, and holidays Have a valid driver's license for the entire duration of the program Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees Ability to lift up to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. Fine motor coordination, depth perception, and ability to hear equipment from a distance Due to potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear PREFERRED QUALIFICATIONS: Associates or Bachelor's Degree Experience working with SOPs, GDP, GMP, CLIA, and the FDA Experience working in a highly regulated or high-volume retail environment Excellent interpersonal, organizational, technical, and leadership skills Equal Employment Opportunity #LI-Remote BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: California - Virtual U.S. Base Salary Range: The estimated salary range reflects an anticipated range for this position. The actual base salaryoffered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-term incentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsCalifornia - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt Yes

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Senior Operations Management Trainee (Senior OMT) About BioLife Plasma Services Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. Equal Employment Opportunity Are you a senior leader interested in bringing your expertise to a place where you can feel good about the work you do? Do you want to develop new skills and set yourself up for continued growth? As a Senior Operations Management Trainee at BioLife, you will participate in an advanced leadership development program that will take you to our plasma centers across the country. You'll travel up to 95% of the time to learn the business while networking with supportive leaders and prepare yourself for accelerated career growth. Our growth is your bright future. Opportunities to grow as a leader are within your reach. With the incredible growth of 220+ BioLife Plasma Services centers across the U.S., the future looks bright for you. When you work at BioLife, you'll feel good knowing what you do makes a difference. A typical day for you may include: Continuous Learning & Development: The expedited training program lasts approximately six months. Upon completion, you'll have 12 months to obtain a Plasma Center Manager position. During this time, you'll receive hands-on experience and have mentorship opportunities. Drive your own learning plan that covers all aspects of managing our high-volume blood plasma collection facilities. Team Management: You'll use your interpersonal and communication skills to cultivate a positive environment and motivate a team of diverse individuals. Provide employee feedback, conduct performance reviews, support team members' development, participate in staff planning and recruiting, and engage and retain employees. Career Advancement: Work towards obtaining a Plasma Center Operations Manager position by completing the training program, networking, and building relationships across BioLife. As you progress your career at BioLife, you'll have opportunities to open and operate brand new plasma centers. Supportive Teamwork: You'll work in our fast-paced, team environment; provide operational support; conduct management training; problem-solve; and communicate with senior management. Exceptional Customer Service: Retain donors by creating a positive donor experience. You may also assist with production. Travel Opportunities: Learn from and network with BioLife team members across the country. You'll be able to return home every other weekend. REQUIRED QUALIFICATIONS: 3-5 years of experience leading medium to large teams (20+ direct reports) Up to 90-100% travel during the Trainee Program Ability to walk and/or stand for the entire work shift Willingness to travel and work at various BioLife locations across the country Ability to work evenings, weekends, and holidays Have a valid driver's license for the entire duration of the program Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees Ability to lift up to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. Fine motor coordination, depth perception, and ability to hear equipment from a distance Due to potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear PREFERRED QUALIFICATIONS: Associates or Bachelor's Degree Experience working with SOPs, GDP, GMP, CLIA, and the FDA Experience working in a highly regulated or high-volume retail environment Excellent interpersonal, organizational, technical, and leadership skills Equal Employment Opportunity #LI-Remote BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: California - Virtual U.S. Base Salary Range: The estimated salary range reflects an anticipated range for this position. The actual base salaryoffered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-term incentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsCalifornia - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt Yes

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description $4000 Sign On Bonus Available! Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About BioLife Plasma Services Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a Medical Support Specialist (Plasma Center Nurse) to support plasma center operations. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will determine donor eligibility to donate plasma, management of donor adverse events, review of laboratory test results, and donor notification of unsuitable test results. The Medical Support Specialist (Plasma Center Nurse) works under the guidance of the Center Manager (or Assistant Manager as applicable) for operational guidance and under the management of the Center Physician for medical issues. The Medical Support Specialist will be familiar with regulations of the plasma collection industry or a manufacturing environment. The Medical Support Specialist follows guidance provided by BioLife Medical Affairs and provides center level support of environmental, health and safety (EHS). How you will contribute You will determine donor eligibility; to include, proper management of informed consent, AIDS education and confidential self-exclusion, medical history interview and acceptance requirements, physical examination, blood testing, and reviewing Serological Protein Electrophoresis (SPE). You will evaluate donor reaction(s), which occurs at the facility as outlined in the SOPs. Follow applicable SOPs for medical emergencies including the development of Center Physician's standing orders and donor transport to emergency care facilities. You will refer to the Center Physician or Medical Affairs (as applicable) when in need of providing unacceptable findings to donors, or guidance concerning medical or technical issues, including donor safety and eligibility. You will support the Hepatitis B and Seasonal Flu vaccination programs for employees as applicable. You will manage employee incidents and determine whether further evaluation is required by occupational health/ER. Refer to EHS guidance regarding employee incidents. You can be a Pandemic Coordinator when authorized by EHS and support investigations associated with pandemic threats within the local community as indicated by EHS or Medical Affairs. What you bring to Takeda: High school diploma or equivalent to including graduate equivalent of a recognized educational nursing program with state requirements Currently licensed or certified in the state where responsibilities will be assigned: Registered Nurse (RN), Nurse Practitioner (NP) or Physician Assistant (PA) Current Cardiopulmonary Resuscitation (CPR) and AED certification Fulfill state requirements (in state of licensure) for basic IV therapy Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist Two years in a clinical or hospital setting What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include medical/dental, paid time off and retirement benefits, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to bring Better Health and a Brighter Future to people around the world. BioLife Compensation and BenefitsSummary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - CA - Lemon Grove U.S. Hourly Wage Range: $38.64 - $53.13 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - CA - Lemon GroveWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt No

Bilingual Registered Nurse - Full Time at Biolife Plasma Services summary: This full-time Bilingual Registered Nurse position at BioLife Plasma Services involves determining donor eligibility, managing adverse events, reviewing lab results, and supporting plasma center operations under medical and managerial guidance. The role requires compliance with regulatory standards, participation in vaccination programs, and potential involvement in pandemic response efforts. Candidates must hold a current RN license, CPR/AED certification, and have clinical experience. By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About BioLife Plasma Services Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a Medical Support Specialist (Plasma Center Nurse) to support plasma center operations. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will determine donor eligibility to donate plasma, management of donor adverse events, review of laboratory test results, and donor notification of unsuitable test results. The Medical Support Specialist (Plasma Center Nurse) works under the guidance of the Center Manager (or Assistant Manager as applicable) for operational guidance and under the management of the Center Physician for medical issues. The Medical Support Specialist will be familiar with regulations of the plasma collection industry or a manufacturing environment. The Medical Support Specialist follows guidance provided by BioLife Medical Affairs and provides center level support of environmental, health and safety (EHS). How you will contribute • You will determine donor eligibility; to include, proper management of informed consent, AIDS education and confidential self-exclusion, medical history interview and acceptance requirements, physical examination, blood testing, and reviewing Serological Protein Electrophoresis (SPE). • You will evaluate donor reaction(s), which occurs at the facility as outlined in the SOPs. Follow applicable SOPs for medical emergencies including the development of Center Physician's standing orders and donor transport to emergency care facilities. • You will refer to the Center Physician or Medical Affairs (as applicable) when in need of providing unacceptable findings to donors, or guidance concerning medical or technical issues, including donor safety and eligibility. • You will support the Hepatitis B and Seasonal Flu vaccination programs for employees as applicable. • You will manage employee incidents and determine whether further evaluation is required by occupational health/ER. Refer to EHS guidance regarding employee incidents. • You can be a Pandemic Coordinator when authorized by EHS and support investigations associated with pandemic threats within the local community as indicated by EHS or Medical Affairs. What you bring to Takeda: • High school diploma or equivalent to including graduate equivalent of a recognized educational nursing program with state requirements • Currently licensed or certified in the state where responsibilities will be assigned: Registered Nurse (RN), Nurse Practitioner (NP) or Physician Assistant (PA) • Current Cardiopulmonary Resuscitation (CPR) and AED certification • Fulfill state requirements (in state of licensure) for basic IV therapy • Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist • Two years in a clinical or hospital setting More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to bring Better Health and a Brighter Future to people around the world. BioLife Compensation and BenefitsSummary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - CA - Lemon Grove U.S. Hourly Wage Range: $38.64 - $53.13 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - CA - Lemon GroveWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt No Keywords: Registered Nurse, plasma donation, donor eligibility, medical support specialist, CPR certification, clinical nursing, adverse event management, healthcare compliance, bilingual nurse, patient care

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Monday - Friday 6:30AM - 3:00PM The Manufacturing Technician 1 performs fundamental tasks within a GMP environment in support of more complex manufacturing operations. The Tasks include, but are not limited to, cleaning and maintaining the work place so that it meets the standards for controlling bioburden levels; cleaning operating equipment per applicable procedures so that it meets the standards established to prevent product contamination and maintaining records/logs neatly and accurately and in accordance with current standard procedures. The technician performs job tasks in a safe manner while following specific department safety rules. PRIMARY RESPONSIBILITIES: * Responsible for equipment setup and operation in a biologics processing environment for plasma derived pharmaceuticals * Detailed cleaning of equipment/facilities to MSP/cGMP standards. * Complete technical training profile as required. * Strict adherence to Dept. Safety Rules * Bulk processing and filtration involving monitoring processing parameters (i.e. pH, weights, separation, assay results..) * Perform real-time documentation during the production run. ADDITIONAL RESPONSIBILITIES English fluency both verbal and written. Basic math skills with proficiency in metric system. Accurate documentation skills are a must. Basic computer skills. Mechanical aptitude. Must be available to work any shift, including weekends. Ability to work well with others in a team environment is essential. Self-starter with the ability to work independently and use good judgment. Must be able to handle multiple priorities. Must be proactive, results oriented, and have strong attention to detail EDUCATION High school diploma or GED required. Associates Degree or Bachelor's degree preferred. Manufacturing, or experience in pharmaceuticals/biologics processing in a GMP environment is preferred. EXPERIENCE 1-2 years' experience in a manufacturing environment preferred. SKILLS & ABILITIES Accurate documentation and attention to detail oriented. Usage of a 10-key calculator. OCCUPATIONAL DEMANDS Ability to lift/push 50 lbs. All work is performed in a clean room (sanitized) manufacturing environment and must gown up. Must be able to work in a cold environment, job requires bending or standing for prolonged periods. This is accurate at the date of publication. It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position. Other duties may be assigned. EEO Minorities/Females/Disability/Veterans BENEFITS * The estimated pay scale for the Manufacturing Technician I role based in Vista, CA is $21.51 - $32.26/hour depending on experience * Additionally, the position is eligible to participate in up to 5% of the company bonus pool * We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement * Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data #biomatusa Location: NORTH AMERICA : USA : CA-Vista:[[cust_building]]

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Grifols Diagnostic Solutions Inc is seeking a Technical Document Editor to help support our Labeling Team in San Diego, CA. This position will provide formatting and maintenance of technical documentation in support of instrument and software operator manuals, package inserts, SOPs, specifications and training materials. Primary responsibilities for role: + Manages labeling change requests, creates and implements templates, style guides, and documentation standards to ensure consistency and quality across all technical documentation, submits finalized documentation for review and approval from internal departments + Execute on project management tracking and priorities by keeping internal trackers and databases up to date, partnering with stakeholders to provide and maintain accurate data, ensuring deadlines and deliverables are met on time + Identify and inform areas for improvement to Labeling processes, styles, formats, and participate/support in execution of continuous improvement initiatives as appropriate + Liaise with external vendors for submission of translation projects and perform translation reviews of received documentation for consistency in format and layout + Edit and maintain technical documentation including operator manuals, package inserts, and regulatory submission documents in compliance with regulatory requirements and company standards + Edit documents to support Labeling Development in compliance with ISO, cGMP, EU MDR and FDA guidelines, working within established formats and templates + Represent Labeling Development on Core Teams and collaborate closely with cross-functional teams including Regulatory Affairs, Marketing, Research & Development Instruments, Product Support and Quality Assurance to understand project requirements and ensure alignment on editing timelines + Revise documentation as requested by stakeholders + Manage documentation, including version control, review and approvals process, generating clean and redlined drafts in accordance with established procedures + Manage the creation, review, approval, distribution, and archival of all controlled documents within Labeling Development, including label and packaging artwork and drawings, package inserts, operator's manuals, work instructions, SOPs, forms, and quality records + Maintain document repositories and electronic document management systems (eDMS), ensuring accurate document metadata, version control, and document history + Collaborate in-person with cross-functional departments to mitigate operational constraints (batch record discrepancies, GDP errors etc.) + Assist in-person demonstrations related to content of technical documents, especially for instrument and software documentation + Commercial printing of labels and IFUs as required + Organize and maintain department files, databases and spreadsheets + Support and execute on Change Control processes in a timely manner + Support on-site audits and inspections by providing documentation as required + Stay informed about industry trends, best practices and regulatory updates related to technical editing and apply knowledge to continuous improvement initiatives Knowledge, Skills, and Abilities + Advanced proficiency in document authoring and publishing tools such as Adobe FrameMaker. + Experience must be current and used in a professional setting. Proficiency in Madcap Flare is a plus + Strong proficiency in Microsoft Office applications, particularly Word, Excel, and SharePoint + Strong proficiency in editing and proof-reading technical documents, with excellent grammar, punctuation, and clarity + Working knowledge with electronic document management systems (eDMS) such as Documentum, LSQM, MasterControl, and document control software + Working knowledge of MRP and/or ERP systems such as SAP, Axapta, Microsoft Dynamics + Excellent organizational skills and attention to detail + Strong communication skills with the ability to collaborate effectively with cross-functional teams and stakeholders + Working knowledge of quality management systems (QMS) and audit processes + Understanding of Change Request processes (ECRs, ECOs) for material management impacted by document control changes + Excellent written and oral communication, and editorial skills + Strong interpersonal skills; ability to learn new concepts quickly and manage multiple projects at once; comfortable with shifting priorities and schedules + Understanding of regulatory requirements for medical device documentation (e.g., FDA 21 CFR Part 820, ISO 13485) Education Bachelors degree in a relevant field or equivalency is required Experience Minimum of 2 years experience in editing technical documentation Equivalency 6+ years of direct experience in lieu of education and experience, preferably in the medical device or pharmaceutical industry Occupational Demands Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Pay Scale The estimated pay scale for a Technical Document Editor role based in San Diego, CA, is $73,424.05 to $91,780.35. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.** California Personnel Privacy Policy and Notice at Collection **Location: NORTH AMERICA : USA : CA-San Diego:[[cust_building]]** Learn more about Grifols (************************************** **Req ID:** 538212 **Type:** Regular Full-Time **Job Category:** OPERATIONAL TECHNICAL AREA

Want to Expand your career-development potential, your ability to help donors and patients, and your access to professional opportunities? We're growing fast . [You can, too!] There are so many ways Octapharma Plasma can enhance your life and your career. Our strong growth is creating great learning and career development opportunities throughout our company, and especially our donation centers. Because you're someone who loves to learn, enjoys people, and has a real heart to help, we encourage you to join us as a: CA DONOR CENTER TECHNICIAN I This is What You'll Do: Ensure total operation is compliant with state and federal regulations (e.g. FDA approved Standard Operating Procedures, OSHA, CLIA, and GMP) to maintain the highest production standards and ensure facility compliance. Maintain high level of customer service and positive donor experience in line with company values and culture. Maintain cleanliness of work area to ensure a clean and professional environment. Stocks and maintains an orderly work area with sufficient supplies to meet production demands. Maintain Donor Center equipment based on Standard Operating Procedures and applicable manufacturer instructions. Monitor donor conditions, employing techniques to ensure donor comfort, safety, and the quality of plasma product. Maintain Donor confidentiality based on company policy. Maintain complete and accurate record keeping per company's Standard Operating Procedures. Responsible for troubleshooting machine alarms/alerts and perform QCs routinely (defined as daily/monthly) on equipment. Clean any blood or plasma spills and performs proper procedure for disposition of biohazardous waste. Perform other job-related tasks, as assigned. Donor Eligibility: Ensure that donor meets eligibility criteria based on Standard Operating Procedures. Perform donor vitals evaluation per Standard Operations Procedure. Perform finger stick for Microhematocrit and Total Protein determination. Register applicant donors per Standard Operating Procedures. Plasma Collection: Set up and prepare all equipment and disposable supplies for venipuncture and plasmapheresis procedures per standard operating procedures. Disconnect donor after plasmapheresis process is completed per standard operating procedures. Maintain proper ratio to ensure donor safety and quality of product. Operate the automated plasmapheresis machines including response and evaluation of all machine alarms and alerts, responds to donor adverse events, and documents exceptions. Product Processing: Prompt and sterile collection and storage of plasma product and samples per Standard Operating Procedures. Handle tested and untested product, as well as product with unsuitable test results. Properly organize samples and product in a walk-in storage freezer per Standard Operating Procedures. · Prepare product and samples for shipments, per Standard Operating Procedures and federal transportation regulations. Monitor freezer and refrigerator temperatures and immediately inform appropriate personnel if equipment is not functioning properly. Record variance if applicable. This is What It Takes: High school diploma or equivalent (GED) required. Bilingual Spanish speaking is a plus but not required. Three (3) months' experience in clerical or customer service position preferred. Specific certification or licensing based on State requirements. Basic computer knowledge and skills required. Ability to speak, read, write (legibly and accurately), and understand English required. Strong customer service skills required. Strong organizational skills required. Ability to read, follow, and interpret regulations, instructions and manuals required. Ability to understand verbal instruction required. Ability to read numbers on screening equipment and perform basic mathematical calculations required. Effective communication skills required. SCHEDULING: Must be able to workday and evening hours, weekends, holidays, and extended shifts on a frequent basis. Attendance and punctuality required. PHYSICAL REQUIREMENTS: Utilize all required and appropriate PPE (Personal Protective Equipment) at all times. Ability to sit or stand for extended periods. Ability to tug, lift, and pull up to thirty-five pounds. Ability to bend, stoop, or kneel. Occupational exposure to blood borne pathogens. Ability to view video display terminal less than 18” away from face for extended periods of time, up to four (4) hours at a time. Ability to work in an environment with a temperature of -40C or colder for extended periods. Occasional exposure to and handling of dry ice. Ability to perform precise tasks that require repetitive small motor skills, such as drawing blood for diagnostic tests. Ability to use assistive devices if needed for mobility or communication. Do Satisfying Work. Earn Real Rewards and Benefits. Our Benefits Octapharma Plasma offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in Octapharma Plasma's 401(k) Savings Plan; 15 days of Paid Time Off (PTO) and paid observed holidays as designated by the Company. The expected base pay for this position at hiring is $16.95 - $22.60 - $28.25. Please note this wage range reflects what Octapharma Plasma expects to pay for this position at the listed location as of the time of this posting. Individual base pay for a successful candidate within this range is determined by qualifications, skill level, experience, competencies and other relevant factors. Working at Octapharma Plasma We aspire to create a culture in which our employees feel inspired. You may be motivated to connect with donors, lead donation centers to new heights of excellence, or provide ideas and vision at a corporate level. We welcome you to consider all possibilities and see what positions best fit your interests and talents. Join the Octapharma Plasma team More About Octapharma Plasma Inc. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch. Please be advised that, although we may not have an immediate requirement at this time, we are consistently interested in engaging with well-qualified candidates for future opportunities. If you are interested in exploring a career with Octapharma Plasma, please apply. Someone will follow up depending on the current needs, but please be aware correspondence may not be immediate. We expect the application window to close within 60 days from the posting date. Please ensure all applications are submitted before the deadline.

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Monday - Friday 8:00am - 4:30pm Responsible for performing a variety of tasks in a warehouse environment involving the handling and storing of materials, parts, supplies and equipment. PRIMARY RESPONSIBILITIES * Manages temperature-controlled, inventoried material in multiple warehouse locations. * Performs Enterprise Resource Planning (ERP) transactions in SAP. * Processes Transfer Orders (TO's), Goods Receipts (GR's). * Operates various manual and motorized warehouse equipment. * Reprioritizes tasks based on unexpected changes in the schedule and business needs * Maintains training requirements. * Maintains warehouse organization and cleanliness. * Maintains inventory accuracy. * Notifies management if materials experience temperatures out of specification. * Coordinates transfer and reconciliation of materials between facilities and completes required documentation. * Follows all safety and general warehouse rules and policies; maintains professionalism in a regulated environment. COMPETENCIES * Inter- and intradepartmental interaction. * Performs, plans, coordinates material and/or equipment transfers between warehouse locations, as required. * Leads shipping/receiving activities. * Authorized to operate the company vehicle to deliver/retrieve raw materials, semi-finished goods or finished goods and ensures temperature remains within specification. EDUCATION & EXPERIENCE * Typically requires a high school diploma * 0-2 years in related experience. GMP experience in a regulated environment preferred. KNOWLEDGE, SKILLS & ABILITIES Ability to follow oral and written instructions; basic computer knowledge and use of email and system applications; basic organizational skills; attention to detail; basic mathematic skills required; basic knowledge of Personal Protective Equipment (PPE); able to adapt to changing environments; able to communicate effectively among peers; good customer service interaction; able to meet aggressive deadlines in a fast-paced environment. OCCUPATIONAL DEMANDS: May occasionally lift, carry, push, pull or otherwise manipulate objects up to 55 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight frequently or continuously. Additional requirements may include providing assistance to another employee in lifting, carrying, pushing, pulling, or otherwise manipulating objects 100 pounds or greater in weight. May move objects and/or materials using carts, lift trucks or pallet jacks. May work in 2-8C or -20C walk-in units for extended periods of time. Surrounded by a variety of constantly moving, motorized warehouse equipment. May handle dry ice to maintain proper storage temperature for frozen materials. EEO Minorities/Females/Disability/Veterans BENEFITS * The estimated pay scale for the Shipping & Receiving Assocaite I role based in Vista, CA is $18.04 - $27.05/hour depending on experience. Additionally, the position is eligible to participate in up to 5% of the company bonus pool * We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement * Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data #BiomatUSA Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : CA-Vista:USVISTA - Vista CA-995 Park Center Drive-AC

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Grifols Diagnostic Solutions Inc is seeking a Reagent Fill Technician IV to support Grifols Diagnostic's Nucleic Acid Testing (NAT) Manufacturing. The Reagent Fill Technician IV will be responsible for performing manufacturing and assembly of clinical and commercial products. Weighs, measures, and checks raw materials and/or manufacturing parts to assure that batches manufactured contain proper ingredients and quantities. Participates in the filling, aliquoting, and packaging of bulk material into the final product. To succeed in this role, we are seeking candidates to have at least an Associates Degree in Biology, Mechanics, Engineering or related field. With 6 years minimum experience as a reagent fill technician or equivalent in a regulated setting. 2 years' experience troubleshooting fill equipment.7 years minimum experience in a lab setting is highly preferred. Individuals with experience in microliters, sealing process (with temperature and time), Vision Systems, familiar with cleaning process (cleaning pumps and operating autoclave washers) are preferred. **Responsibilities** + Handling and traying of temperature-sensitive (semi-)finished goods for use in blood typing kits + Perform in process visual inspection of temperature-sensitive (semi-)finished goods for use in blood typing kits as they come off the fill line before placement in trays. + Perform sample gathering of temperature-sensitive (semi-)finished goods for use in blood typing kits for QC and Bio-burden. + Receives and verifies the accuracy of materials transferred from the warehouse. + Assists with material handling, folding product boxes/trays and staging of materials for process orders + Understands and executes written procedures in accordance with cGMP. + Performs labor transactions in the Enterprise Resource Planning (ERP) System. + Maintains detailed and accurate device history records with cGMP and forwards them in a timely manner for review. + General manufacturing area housekeeping including cleaning of labware, equipment, totes, shelves, benches and sinks and removing trash. + Ensures proper transportation, handling, and disposal of hazardous, bio-hazardous and/or infectious substances. + Maintains accurate and complete training records. + Maintains and archives Manufacturing log sheet records. + Demonstrate processes during audits, including ISO, FDA and internal audits. + Follows all safety rules. + Must be able to communicate product issues, safety incidences and/or personal issues affecting production timelines. + Independently perform and lead the set-up and operation of reagent filling equipment of at least 90% of automated fill machines. + Primary contact for material transfer delegation + Implement new areas or ideas for 5S + Quality notification (QN) investigations: provide information to the quality notification author to complete the quality notification investigation + Act as mentor and train Reagent Fill Technician I, Reagent Fill Technician II and Reagent Fill Technician III + Lead equipment troubleshooting during the set-up, change over and operation to ensure completion within the scheduled time frame. + Performs device history record review release and collaborates with Quality Assurance on any outstanding issues + Propose updates and edit and format documents including device master records and Standard Operating Procedures (SOP) + Work in cross-functional teams to lead process improvement projects within the filling department + Responsible for printing and distributing the cycle count forms, gathering and reviewing the completed forms, and investigating discrepancies + Quality notification (QN) investigations: provide information to the quality notification author to complete the quality notification investigation **Additional Responsibilities** Cross-functional communication participation. Assists packaging crew as needed. Responsible for flushing water ports and eyewash stations. Adhere to target manufacturing timelines. Punctuality and attendance are required. Attentiveness and openness to learn new processes. Performs refrigerator/freezer maintenance. May cross-train in other areas of manufacturing and operations based on business need. May mentor and help train Reagent Fill Technican I, II and III. Assist with Device History Record (DHR) review. May be responsible for demonstrating manufacturing processes during a customer or regulatory audit. Initiate Quality Notifications (QN). Act as rework coordinator. Initiate lab walkthrough for audit preparation. **Knowledge, Skills, and Abilities** Demonstrated job specific technical knowledge. Intermediate knowledge of laboratory safety and record keeping. Working knowledge of GDP, GMP and ISO Reg. Blood Borne Pathogen Training. Advanced knowledge of Microsoft Office software. Attention to detail, good organizational skills and team oriented. Ability to follow oral and written instructions. Intermediate knowledge of laboratory science, procedures, techniques, instruments & equipment. Ability to effectively communicate with team members and cross-functional departments. **Education:** Requires Associates Degree in Biology, Mechanics, Engineering or related field. **Experience:** 6 years minimum experience as a reagent fill technician or equivalent in a regulated setting. 2 years experience troubleshooting fill equipment. 7 years minimum experience in a lab setting is highly preferred. **Equivalency** Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires an Associate's degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor's degree. **Occupational Demands:** The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Visually inspect components and final kits for compliance and specifications. Close vision (20 inches or less) will be utilized and some color identification will be required. Frequently required to stand, sit, use hands/fingers to handle or feel, perform reaching, bending, stooping or kneeling motions. Operators may be required to walk for a considerable amount of time. May occasionally lift, carry, push, pull or otherwise manipulate objects up to 40 pounds in weight. Will be required to frequently or continuously lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight. May move heavier (greater than 50 pounds) objects and/or materials using carts or pallet jacks. The applicant must be flexible and willing to work evenings and weekends based on the production schedule needs. **PayScale** The estimated pay scale for this **Reagent Fill Technician IV** role based in San Diego, California is $30.30 to $37.87 per hour. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.** California Personnel Privacy Policy and Notice at Collection **Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg** Learn more about Grifols (************************************** **Req ID:** 538126 **Type:** Regular Full-Time **Job Category:** MANUFACTURING

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Grifols Diagnostic Solutions in San Diego, CA is seeking a Quality Control Support Analyst 3. The primary job function of the QC Support analyst 3 is to test and release raw materials, sub-assemblies or finished goods. This role will support our Quality Control Microbiology team. This position is responsible for conducting scheduled Environmental Monitoring (EM), as well as performing water sampling and testing across our manufacturing areas. Additional duties include maintaining inventory of laboratory supplies, sterilizing microbial air sampling heads, and executing microbial testing of clean compressed air. The QC Support Analyst 2 will perform microbial enumeration of rinse samples from manufacturing, swabs designated surfaces to detect viral presence and transcript team plate activities as part of the Contamination Surveillance Program, and tests swab and rinse samples from validation processes. Primary responsibilities for role: * Performs routine testing including release testing, performance testing, analytical testing, bioburden testing, environmental monitoring using GMP/GLP practices. * Performs data analysis and results interpretations comparing to specifications, validity criteria, alert limit * Responsible for maintaining product and QC material inventories. * Responsible for the maintenance and cleanliness of the laboratory, stocking shelves/drawers with testing materials. * Responsible for the maintenance and cleanliness of equipment, calibrating or submitting items for calibration as needed. * Responsible for completing training in a timely manner and maintaining the records. * Responsible for revising QC documents (SOPs, QSs) * Participates in Lab Investigations and Out of Specification investigations. * Responsible for training QC analysts on test methods Knowledge, Skills, and Abilities: * Working knowledge of GMP/GLP. * Intermediate computer skills. * Attention to detail. Education: B.A. or B.S in a Biological Science or Chemistry Experience: 0-2 Equivalency: Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires an Associates degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelors degree. Occupational Demands: May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously. Pay Scale The estimated pay scale for this QC Support Analyst 3 role based in San Diego, CA, is $29.14 to $36.42 per hour. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Grifols Diagnostic Solutions in San Diego, CA is seeking a Regulatory Affairs Specialist III. The Regulatory Affairs Specialist III is responsible for ensuring regulatory compliance and supporting global market access for in vitro diagnostic (IVD) products. It involves developing and executing regulatory strategies, preparing and submitting complex pre-market and post-market applications to FDA, EU Notified Bodies, and other international authorities, and managing communications with health agencies. This role requires collaboration with cross-functional teams, providing regulatory input throughout the product lifecycle, mentoring junior colleagues, and proactively monitoring evolving regulations to identify risks and implement mitigation plans. Strong technical expertise, analytical skills, and the ability to influence stakeholders are essential for success in this position. To qualify for the Regulatory Affairs Specialist III role, candidates must have a Bachelor's degree in life sciences, engineering, or a related field, along with at least 6 years of experience in a regulated environment, including 4 years of direct experience in Regulatory Affairs. Prior experience in the IVD or Drug/Biologics industry is required. **Primary responsibilities for role:** + Prepares and files complex pre-market and post-market regulatory submissions with the US FDA, Notified Bodies in the EU and other international regulatory bodies, as applicable. Prepares clear, complete, and accurate documents that are logically constructed and comprehensive in content according to established templates and timelines. + Tracks submissions, correspondence, and commitments with health authorities and prepares responses and comments from regulatory agencies independently, proactively, in compliance with regulatory guidelines/requirements and according to established timelines. Communicates with Health Authorities and has a demonstrated ability to facilitate requests and anticipate appropriate next steps. + Develop and execute submission strategies based on ability to understand complex technical information, and provide guidance to existing and new cross-functional product core teams for new product development and various on-market enhancements/changes from product concept to placing on the market. Monitor progress on key project deliverables and provide status updates to management on a regular basis. + Collaborate with subject matter experts to ensure regulatory submissions requirements are being met and technical and scientific data are incorporated into regulatory submissions, and collaborate with partners and local liaisons for management of submissions in foreign countries and facilitate meetings with SMEs as needed to track progress. + Execute projects without supervision to align with and achieve the goals and timelines set by management + Makes decisions and influences stakeholders and teammates based on gained regulatory knowledge and experience, technical expertise and current regulatory compliance trends + Communicates moderately complex to complex regulatory topics to cross functional management, modify their communication style to fit the audience by embracing cultural differences and recognizing different knowledge levels. + Proactively research applicable regulations and guidance to the company's products and stay up to date on the current regulatory requirements and industry trends. Assess the impact of applicable regulations to the company's products and be able to identify mitigation plans, lead mitigation projects, and make decisions that will assist in reducing regulatory risk. + Review, provide regulatory input to, and approve various quality management system related documents including utilizing scientific concepts to critically review complex reports, validations, etc. to ensure regulatory requirements are being adequately addressed. + Provide support to lower level regulatory team members by sharing gained regulatory expertise, mentoring, reviewing submissions and/or training to company products and processes. + Assess changes to product for regulatory impact and include regulatory assessments in the established change control systems, as applicable. + Prepare regulatory documentation to support regulatory inspections/audits and to meet auditor/inspector requests + Identify process improvement initiatives and drives their successful execution + Provides regular status updates on projects to management. + Additional duties assigned as needed. **Knowledge, Skills, and Abilities** + This position requires a person with commitment to excellence, and ability to work in a fast-paced, technically skilled, team setting. + Demonstrated ability to independently coordinate and manage complex projects, prioritize multiple responsibilities and drive projects to completion + Demonstrated ability to strike a balance between independent work and team interaction, be a team player in a cross-functional team + Demonstrated interpersonal skills, with experience in interacting with and influencing people, building strong positive relationships + Demonstrated ability to identify issues, understand their urgency, escalate to management, and provide solutions. + Demonstrated understanding of IVD regulations, advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices. + Strong oral and written communication and presentation skills, capable of presenting and explaining complicated concepts to colleagues within the organization + Strong technical writing skills with ability to translate scientific information into technical documentation for submission to regulatory authorities + Demonstrates expert attention to detail with ability to identify areas of improvement and possible inconsistencies in documentation + Expert analytical and problem-solving skills, capable of identifying problems, determining root cause and providing solutions to management + Demonstrated ability to communicate with FDA and international customers (e.g., regulatory agencies, business partners, etc.) + Exceptional computer skills in Microsoft Office, Adobe, Excel + Knowledge in document management control systems (e.g. LSQM), change control systems (e.g. SAP), JIRA, required **Education** Bachelor's Degree required in the life sciences, engineering or similarly related field **Experience** 6 years of experience in a regulated environment with 4 years direct experience in Regulatory Affairs. IVD or Drug/Biologics Industry experience required. **Equivalency** Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. **Occupational Demands** Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. **Pay Scale** The estimated pay scale for the Regulatory Affairs Specialist III role based in **San Diego, CA** , is **$105,800 to $132,250** per year. Additionally, the position is eligible to participate in up to **8** % of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! \#LI-DC1 Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.** California Personnel Privacy Policy and Notice at Collection **Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg** Learn more about Grifols (************************************** **Req ID:** 537543 **Type:** Regular Full-Time **Job Category:** TECHNICAL

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Grifols Diagnostic Solutions in San Diego, CA is seeking a Senior Supplier Quality Engineer. The Sr Supplier Quality Engineer will function as a primary quality lead on cross-functional teams focusing on **new materials** , suppliers' qualification, and supplier changes. **This position will be responsible for development and updates of material specifications and ensure that correct and appropriate specifications have been created and approved** . The Sr Supplier Quality Engineer will ensure that correct and appropriate internal and external requirements, standards, and regulations are applied in the Quality Management System. To be successful in this position, we are seeking individuals with at least a minimum Bachelor's degree in biology, chemistry, biochemistry, biomedical engineering or related field. Along with a minimum of 8 years of relatable work experience in Quality Assurance and 5-year prior experience in Supplier Management. For this role, we are seeking individuals with experience in injection molding and plastics (direct expertise, maintenance, quality). **Primary responsibilities for role:** + Applies risk-based approach for creation and execution of the annual supplier audit program, providing guidance to the team for the successful completion. + Develops and executes qualification program for new materials and suppliers using risk-based approach. Defines and monitors supplier risk-level by evaluating material using the supplier risk-tool and ensures that the supplier and material meets Grifols requirements. + Provides rationale for the supplier status event report and ensures the appropriate actions were addressed and are timely completed. + Ensures the appropriate Vendor Notification process is established and the communication of nonconformances (SCAR) to suppliers is maintained, ensures that property investigation is conducted, root cause is analyzed, and corrective plans are appropriated and assigned, working internally with cross-functional Grifols teams and external Suppliers. Provides technical assessment on the effectiveness of resolutions of Supplier issues. + Lead internal investigations to appropriately define root-cause of Low, Medium and High-risk material and supplier related issues. Applies appropriate statistical methods to effectively creates the corrective and preventive plans. Ensures on-time and appropriate closure of supplier actions (SCAR). + Reviews, approves and monitors the Supplier Qualification and Performance (scorecard). Ensures all follow-up action items are timely completed. + Collaborates with Grifols suppliers to provide technical assessment and approval on the required suppliers quality documentation, such as Questionnaires, and approves plans for improvement. + Develops and trends Supplier Quality System metric to identify opportunities for improvements + Creates, reviews and approves supplier quality procedures, providing feedback, improvements and implement action items on the Supplier Quality Management System procedures and documentation to ensure compliance with Grifols and external requirements and regulations + Assesses the quality agreements between Grifols suppliers in a timely manner for approval of supplier qualification. + Independently conducts and approves external and/or internal audits. Approves audit report and, ensures final audit report and any associated nonconformances to the supplier are accordingly completed, as applicable + Independently authors, provides technical assessment during the review and approval of raw-material specifications to support approval of supplier and material qualification + Takes the ownership of critical issues, leads and stakeholder meetings, writes minutes and follows up on action items and summarizes conclusions and provides technical assessment on supplier related change control processes and monitors change implementation. + Writes and approves technical assessments on supplier change notifications. Serves as a Subject Matter Expert in supporting the assessment and approval of Supplier change notifications, assessing the impact on the product quality and Quality Management System. + Provides Technical assessment for the development of new employee quality system or procedural training and develop department training programs, as needed + Hosts 3rd Party Audits from regulatory bodies including the FDA, notified bodies and business. **Knowledge, Skills, and Abilities** + Excellent writing skills, including independently writing SOPs, forms, and risk assessments. Must be a strong technical writer. + Excellent presentation skills, including independently preparing, organizing and presenting information based on the audience. + Knowledge of material, formulation and manufacturing process. + Strong communication skills with an ability to convey ideas clearly to all levels within a cross functional team. + Proficient in Microsoft Office Suite. + Knowledge and proof of experience of Good Manufacturing Practice processes and procedures. + Willing to work collaboratively to identify and implement a sustainable solution. + Strong attention to detail and ability to analyze data using statistical software. + Strong project management and organizational skills with the ability to work on multiple projects with competing deadlines. + Represents Quality Assurance interests on special projects related to new material, changes of materials and supplier management. + Ability to train and mentor within and outside the group. **Education** Minimum: Bachelor's degree in biology, chemistry, biochemistry, biomedical engineering or related field **Experience** + A minimum of 8 years of relatable work experience in Quality Assurance. + 5-year prior experience in Supplier Management. + Technical writing, trend analysis and lead projects experience is preferred + Prior experience working with an electronic document management system is required. + Experience implementing changes, trend analysis and improvements is a plus. + Prior experience working with SAP is a plus. **Occupational Demands** Work is performed in an office environment with exposure to electrical office equipment. May occasionally enter BioRisk Area. Exposure to biological fluids with potential exposure to infectious organisms. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Drives varies may or may be required to frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. **Pay Scale** The estimated pay scale for a Senior Supplier Quality Engineer role based in San Diego, California is $116,032.70 to $145,040.30. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! \#LI-DC1 Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.** California Personnel Privacy Policy and Notice at Collection **Location: NORTH AMERICA : USA : CA-San Diego:[[cust_building]]** Learn more about Grifols (************************************** **Req ID:** 536239 **Type:** Regular Full-Time **Job Category:** TECHNICAL

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Grifols Diagnostic Solutions is seeking a Staff Systems Engineer to join our R&D Instrument Systems team. This position is located in San Diego, CA and is reporting to the Senior Manager, Systems and Validation. The Staff Systems Engineer shall be an experienced, cross-functional technical leader who will be responsible for supporting all phases of complex Nucleic Acid Testing in-vitro diagnostics (IVD) system development. As a technical lead they will work as a subject matter expert to solve complex technical challenges involving hardware, software consumables and the interaction with assay development. They will lead the Systems Engineering team in subsystem definition, integration, verification and subsystem failure investigations to ensure that critical sub-systems meet their individual performance, interface and system integration goals. In order to be successful in this role, we are looking for individuals to have at least 12 years' hands on experience developing electromechanical systems/subsystems for complex medical instruments, 7 years' experience as a Systems Engineer leading the architectural design and engineering of complex instruments, and 5 years of experience in requirements management. **Primary Responsibilities for Role** + Leads Systems Engineering efforts during the subsystem integration and verification testing phases to ensure that critical sub-systems meet their individual performance, interface and system integration goals and to ensure that the fully integrated system robustly meets its performance, safety and cost requirements + Lead Systems Engineers in translating system level requirements from cross functional teams into product architecture and system level design including partitioning functionality into sub-systems, creating specifications for each sub-system, and documenting the interface requirements among the sub-system + Resolve interface issues and have the ability to document theory of operations of complex medical product designs + Design, architecture, and development of electromechanical device with embedded software + Ensure compliance to the Product Development Process, Risk Management and Quality Systems + Deliver system engineering deliverables in a timely manner to support the execution of development projects including system requirements, hardware subsystem requirements, hardware, and software dFMEAs + Utilize a growth mindset to continuously improve our Systems Engineering capabilities + Work with verification and validation engineers to define test strategies for the development of verification plans and validation plans using requirement tracing methods + Ability to mentor Systems Engineers **Additional Responsibilities** + May be responsible for leading and/or managing other systems experts **Knowledge, Skills, and Abilities** + Experienced in System Engineering techniques such as model based system engineering + Advanced knowledge of standards including IEC 60601, ISO 14971, ISO 13485 and 62366 + Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise. + Demonstrated ability to translate high level product requirements into system and sub- system level specifications and designs System and hardware architecture definition and design + Ability to independently analyze and complex mechanical designs, circuitry and software using drawings, schematics, source code, technical education, and experience. + Excellent verbal and written communications skills. Demonstrated success in technical decision making and people management/leadership in a matrix environment. + Proven track record of developing complex products in a highly regulated environment + Requirements management using tools such as JAMA/JIRA a plus + Education + Minimum requirement: Bachelor's Degree in a technical discipline such as Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Electrical Engineering, Life Sciences or equivalent **Experience** + 12+ years of experience developing electromechanical systems/subsystems for complex medical instruments + 7+ years of experience as a Systems Engineer, leading the architectural design and systems engineering of complex instruments + 5+ years of experience in requirements management **Equivalency** Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. **Occupational Demands** Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequently walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. **Pay Scale** The estimated pay scale for the Staff Systems Engineer role based in San Diego, California, is $161,554.30 to $201,943.45 per year. Additionally, the position is eligible to participate in up to 15% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! \#LI-DC1 Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.** California Personnel Privacy Policy and Notice at Collection **Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg** Learn more about Grifols (************************************** **Req ID:** 536681 **Type:** Regular Full-Time **Job Category:** R & D

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Grifols Diagnostic Solutions Inc is seeking a Senior Engineer in San Diego, CA. This position is a key member of the Manufacturing Technical Support team responsible for technical leadership and direct support for diagnostics manufacturing operations. This role integrates expertise in mechanical design, electrical systems, reliability engineering, and industrial automation to ensure the performance, compliance, and reliability of our production equipment. The ideal candidate will play a key role in supporting the manufacture of high-quality diagnostic products that impact global health. Leads / manages cross-functional engineering projects for implementation of new capital investments (engineering design, start-up and qualification of GMP process equipment). Assures continuous improvement of automated Filling, Labeling, Packaging, Oligosynthesis, Bulk equipment and processes. We are seeking individuals with at least a Bachelors in Mechanical or Electrical Engineering, or related field. Along with 7 years of related industry experience and at least 1 year of experience in pharmaceutical/biotech operations, with thorough working knowledge production unit operations and validation principles. Primary Responsibilities * Completion of design and engineering projects within schedule, budget and quality requirements. * Analyze reliability data and Implement equipment and process improvement projects to improve equipment up-time and Overall Equipment Effectiveness (OEE) * Ability to evaluate legacy equipment/systems and propose improvements to cycle time, quality compliance, data integrity. * Lead mechanical and electrical design improvements for custom manufacturing equipment including Filling, Labeling, Packaging equipment. * Experience leading project design, FAT, SAT, start-up, commissioning and qualification of new equipment and utilities. * Support root cause investigations for quality events and reliability issues. Perform technical assessments for process and equipment issues, driving preventive actions. Offer long term solutions to identified problems. * Support project teams focused on technology transfer, introduction of new products or processes, process improvements. Provide feasibility assessments and process and equipment requirements. * Employ advanced engineering principles within area of engineering expertise; ability to apply knowledge of engineering principles and practices outside of area of discipline expertise. * Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity. Propose improvements and different approaches to solve problems * Perform PFMECA and reliability modeling to support risk-based decision-making. * Mentor junior engineers and mechanics, fostering a culture of technical excellence and innovation. * Documentation and creation of guides, processes and methods for the Engineering team. * After hours and shift support may be required. (On-Call) Knowledge, Skills, and Abilities * Direct experience working in regulated environments (i.e. cGMP, OSHA, ISO) required. * Ability to design and develop Mechanical solutions and prototypes using Solidworks. 3D model design and 2D drawings of mechanical parts and assemblies, following the required regulations, good practices and industry standards. * Ability to design and develop Electrical solutions for improving the equipment, using AutoCad electrical to create and update electrical drawings following the required regulations, good practices and industry standards. * Fast learner with proven capability to quickly adapt to new technologies and systems. * Working knowledge of fully automated liquid filing and labeling equipment. * Strong troubleshooting skills across a wide range of equipment and systems. * Capable of working independently, assessing situations to determine when to request support. * Highly motivated self-starter with the ability to take initiative and drive tasks to completion. * Demonstrated success in leading cross-functional engineering projects. * Knowledge of data integrity (ALCOA+), Industry 4.0, and smart factory technologies. * Knowledge of computerized maintenance management systems (SAP, Maximo). * Experience with in-line printing systems (Novexx, Zebra) and automated label application equipment is preferred. * Experience with oligosynthesis, HPLC instrumentation and RO/DI purified water systems is preferred. * 3D printing knowledge is preferred * Ability to troubleshoot PLC/HMI systems (Allen Bradley), Vision systems (Cognex, Keyence) and Robotics (Staubli) is preferred. * Experience with materials selection and analysis for plastics, glass, and stainless steel is preferred. Education BS Mechanical or Electrical Engineering, or related field. Experience * Minimum 7 years related industry experience required. * 1+ year experience in pharmaceutical/biotech operations, with thorough working knowledge production unit operations and validation principles. Equivalency Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. Occupational Demands Ability to lift up to 50 lbs. Wear PPE as required for job duties in an industrial plant work environment. Pay Scale The estimated pay scale for this Senior Engineer role based in San Diego, CA, is $112,388.35 to $140,486.30 per year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

The Registered Nurse (RN) at BioLife Plasma Services supports plasma center operations by determining donor eligibility, managing donor reactions, reviewing lab results, and ensuring compliance with medical and safety regulations. The role involves collaboration with the Center Manager and Center Physician to uphold donor safety and quality standards. This position requires licensure as an RN, clinical experience, and adherence to FDA training standards within a regulatory environment focused on plasma collection. By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About BioLife Plasma Services Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a Medical Support Specialist (Plasma Center Nurse) to support plasma center operations. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will determine donor eligibility to donate plasma, management of donor adverse events, review of laboratory test results, and donor notification of unsuitable test results. The Medical Support Specialist (Plasma Center Nurse) works under the guidance of the Center Manager (or Assistant Manager as applicable) for operational guidance and under the management of the Center Physician for medical issues. The Medical Support Specialist will be familiar with regulations of the plasma collection industry or a manufacturing environment. The Medical Support Specialist follows guidance provided by BioLife Medical Affairs and provides center level support of environmental, health and safety (EHS). How you will contribute You will determine donor eligibility; to include, proper management of informed consent, AIDS education and confidential self-exclusion, medical history interview and acceptance requirements, physical examination, blood testing, and reviewing Serological Protein Electrophoresis (SPE). You will evaluate donor reaction(s), which occurs at the facility as outlined in the SOPs. Follow applicable SOPs for medical emergencies including the development of Center Physician's standing orders and donor transport to emergency care facilities. You will refer to the Center Physician or Medical Affairs (as applicable) when in need of providing unacceptable findings to donors, or guidance concerning medical or technical issues, including donor safety and eligibility. You will support the Hepatitis B and Seasonal Flu vaccination programs for employees as applicable. You will manage employee incidents and determine whether further evaluation is required by occupational health/ER. Refer to EHS guidance regarding employee incidents. You can be a Pandemic Coordinator when authorized by EHS and support investigations associated with pandemic threats within the local community as indicated by EHS or Medical Affairs. What you bring to Takeda: High school diploma or equivalent to including graduate equivalent of a recognized educational nursing program with state requirements Currently licensed or certified in the state where responsibilities will be assigned: Registered Nurse (RN), Nurse Practitioner (NP) or Physician Assistant (PA) Current Cardiopulmonary Resuscitation (CPR) and AED certification Fulfill state requirements (in state of licensure) for basic IV therapy Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist Two years in a clinical or hospital setting What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include medical/dental, paid time off and retirement benefits, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to bring Better Health and a Brighter Future to people around the world. BioLife Compensation and BenefitsSummary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - CA - San Marcos U.S. Hourly Wage Range: $36.96 - $50.82 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - CA - San MarcosWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt No Keywords: Registered Nurse, plasma donation, donor eligibility, medical support specialist, clinical nursing, plasma center operations, FDA compliance, donor safety, healthcare nursing, CPR certification

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Grifols Diagnostic Solutions Inc is seeking a Technical Document Editor to help support our Labeling Team in San Diego, CA. This position will provide formatting and maintenance of technical documentation in support of instrument and software operator manuals, package inserts, SOPs, specifications and training materials. Primary responsibilities for role: * Manages labeling change requests, creates and implements templates, style guides, and documentation standards to ensure consistency and quality across all technical documentation, submits finalized documentation for review and approval from internal departments * Execute on project management tracking and priorities by keeping internal trackers and databases up to date, partnering with stakeholders to provide and maintain accurate data, ensuring deadlines and deliverables are met on time * Identify and inform areas for improvement to Labeling processes, styles, formats, and participate/support in execution of continuous improvement initiatives as appropriate * Liaise with external vendors for submission of translation projects and perform translation reviews of received documentation for consistency in format and layout * Edit and maintain technical documentation including operator manuals, package inserts, and regulatory submission documents in compliance with regulatory requirements and company standards * Edit documents to support Labeling Development in compliance with ISO, cGMP, EU MDR and FDA guidelines, working within established formats and templates * Represent Labeling Development on Core Teams and collaborate closely with cross-functional teams including Regulatory Affairs, Marketing, Research & Development Instruments, Product Support and Quality Assurance to understand project requirements and ensure alignment on editing timelines * Revise documentation as requested by stakeholders * Manage documentation, including version control, review and approvals process, generating clean and redlined drafts in accordance with established procedures * Manage the creation, review, approval, distribution, and archival of all controlled documents within Labeling Development, including label and packaging artwork and drawings, package inserts, operator's manuals, work instructions, SOPs, forms, and quality records * Maintain document repositories and electronic document management systems (eDMS), ensuring accurate document metadata, version control, and document history * Collaborate in-person with cross-functional departments to mitigate operational constraints (batch record discrepancies, GDP errors etc.) * Assist in-person demonstrations related to content of technical documents, especially for instrument and software documentation * Commercial printing of labels and IFUs as required * Organize and maintain department files, databases and spreadsheets * Support and execute on Change Control processes in a timely manner * Support on-site audits and inspections by providing documentation as required * Stay informed about industry trends, best practices and regulatory updates related to technical editing and apply knowledge to continuous improvement initiatives Knowledge, Skills, and Abilities * Advanced proficiency in document authoring and publishing tools such as Adobe FrameMaker. * Experience must be current and used in a professional setting. Proficiency in Madcap Flare is a plus * Strong proficiency in Microsoft Office applications, particularly Word, Excel, and SharePoint * Strong proficiency in editing and proof-reading technical documents, with excellent grammar, punctuation, and clarity * Working knowledge with electronic document management systems (eDMS) such as Documentum, LSQM, MasterControl, and document control software * Working knowledge of MRP and/or ERP systems such as SAP, Axapta, Microsoft Dynamics * Excellent organizational skills and attention to detail * Strong communication skills with the ability to collaborate effectively with cross-functional teams and stakeholders * Working knowledge of quality management systems (QMS) and audit processes * Understanding of Change Request processes (ECRs, ECOs) for material management impacted by document control changes * Excellent written and oral communication, and editorial skills * Strong interpersonal skills; ability to learn new concepts quickly and manage multiple projects at once; comfortable with shifting priorities and schedules * Understanding of regulatory requirements for medical device documentation (e.g., FDA 21 CFR Part 820, ISO 13485) Education Bachelors degree in a relevant field or equivalency is required Experience Minimum of 2 years experience in editing technical documentation Equivalency 6+ years of direct experience in lieu of education and experience, preferably in the medical device or pharmaceutical industry Occupational Demands Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Pay Scale The estimated pay scale for a Technical Document Editor role based in San Diego, CA, is $73,424.05 to $91,780.35. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Grifols Diagnostic Solutions Inc is seeking a Reagent Fill Technician IV to support Grifols Diagnostic's Nucleic Acid Testing (NAT) Manufacturing. The Reagent Fill Technician IV will be responsible for performing manufacturing and assembly of clinical and commercial products. Weighs, measures, and checks raw materials and/or manufacturing parts to assure that batches manufactured contain proper ingredients and quantities. Participates in the filling, aliquoting, and packaging of bulk material into the final product. To succeed in this role, we are seeking candidates to have at least an Associates Degree in Biology, Mechanics, Engineering or related field. With 6 years minimum experience as a reagent fill technician or equivalent in a regulated setting. 2 years' experience troubleshooting fill equipment.7 years minimum experience in a lab setting is highly preferred. Individuals with experience in microliters, sealing process (with temperature and time), Vision Systems, familiar with cleaning process (cleaning pumps and operating autoclave washers) are preferred. Responsibilities * Handling and traying of temperature-sensitive (semi-)finished goods for use in blood typing kits * Perform in process visual inspection of temperature-sensitive (semi-)finished goods for use in blood typing kits as they come off the fill line before placement in trays. * Perform sample gathering of temperature-sensitive (semi-)finished goods for use in blood typing kits for QC and Bio-burden. * Receives and verifies the accuracy of materials transferred from the warehouse. * Assists with material handling, folding product boxes/trays and staging of materials for process orders * Understands and executes written procedures in accordance with cGMP. * Performs labor transactions in the Enterprise Resource Planning (ERP) System. * Maintains detailed and accurate device history records with cGMP and forwards them in a timely manner for review. * General manufacturing area housekeeping including cleaning of labware, equipment, totes, shelves, benches and sinks and removing trash. * Ensures proper transportation, handling, and disposal of hazardous, bio-hazardous and/or infectious substances. * Maintains accurate and complete training records. * Maintains and archives Manufacturing log sheet records. * Demonstrate processes during audits, including ISO, FDA and internal audits. * Follows all safety rules. * Must be able to communicate product issues, safety incidences and/or personal issues affecting production timelines. * Independently perform and lead the set-up and operation of reagent filling equipment of at least 90% of automated fill machines. * Primary contact for material transfer delegation * Implement new areas or ideas for 5S * Quality notification (QN) investigations: provide information to the quality notification author to complete the quality notification investigation * Act as mentor and train Reagent Fill Technician I, Reagent Fill Technician II and Reagent Fill Technician III * Lead equipment troubleshooting during the set-up, change over and operation to ensure completion within the scheduled time frame. * Performs device history record review release and collaborates with Quality Assurance on any outstanding issues * Propose updates and edit and format documents including device master records and Standard Operating Procedures (SOP) * Work in cross-functional teams to lead process improvement projects within the filling department * Responsible for printing and distributing the cycle count forms, gathering and reviewing the completed forms, and investigating discrepancies * Quality notification (QN) investigations: provide information to the quality notification author to complete the quality notification investigation Additional Responsibilities Cross-functional communication participation. Assists packaging crew as needed. Responsible for flushing water ports and eyewash stations. Adhere to target manufacturing timelines. Punctuality and attendance are required. Attentiveness and openness to learn new processes. Performs refrigerator/freezer maintenance. May cross-train in other areas of manufacturing and operations based on business need. May mentor and help train Reagent Fill Technican I, II and III. Assist with Device History Record (DHR) review. May be responsible for demonstrating manufacturing processes during a customer or regulatory audit. Initiate Quality Notifications (QN). Act as rework coordinator. Initiate lab walkthrough for audit preparation. Knowledge, Skills, and Abilities Demonstrated job specific technical knowledge. Intermediate knowledge of laboratory safety and record keeping. Working knowledge of GDP, GMP and ISO Reg. Blood Borne Pathogen Training. Advanced knowledge of Microsoft Office software. Attention to detail, good organizational skills and team oriented. Ability to follow oral and written instructions. Intermediate knowledge of laboratory science, procedures, techniques, instruments & equipment. Ability to effectively communicate with team members and cross-functional departments. Education: Requires Associates Degree in Biology, Mechanics, Engineering or related field. Experience: 6 years minimum experience as a reagent fill technician or equivalent in a regulated setting. 2 years experience troubleshooting fill equipment. 7 years minimum experience in a lab setting is highly preferred. Equivalency Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires an Associate's degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor's degree. Occupational Demands: The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Visually inspect components and final kits for compliance and specifications. Close vision (20 inches or less) will be utilized and some color identification will be required. Frequently required to stand, sit, use hands/fingers to handle or feel, perform reaching, bending, stooping or kneeling motions. Operators may be required to walk for a considerable amount of time. May occasionally lift, carry, push, pull or otherwise manipulate objects up to 40 pounds in weight. Will be required to frequently or continuously lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight. May move heavier (greater than 50 pounds) objects and/or materials using carts or pallet jacks. The applicant must be flexible and willing to work evenings and weekends based on the production schedule needs. PayScale The estimated pay scale for this Reagent Fill Technician IV role based in San Diego, California is $30.30 to $37.87 per hour. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Grifols Diagnostic Solutions in San Diego, CA is seeking a Regulatory Affairs Specialist III. The Regulatory Affairs Specialist III is responsible for ensuring regulatory compliance and supporting global market access for in vitro diagnostic (IVD) products. It involves developing and executing regulatory strategies, preparing and submitting complex pre-market and post-market applications to FDA, EU Notified Bodies, and other international authorities, and managing communications with health agencies. This role requires collaboration with cross-functional teams, providing regulatory input throughout the product lifecycle, mentoring junior colleagues, and proactively monitoring evolving regulations to identify risks and implement mitigation plans. Strong technical expertise, analytical skills, and the ability to influence stakeholders are essential for success in this position. To qualify for the Regulatory Affairs Specialist III role, candidates must have a Bachelor's degree in life sciences, engineering, or a related field, along with at least 6 years of experience in a regulated environment, including 4 years of direct experience in Regulatory Affairs. Prior experience in the IVD or Drug/Biologics industry is required. Primary responsibilities for role: * Prepares and files complex pre-market and post-market regulatory submissions with the US FDA, Notified Bodies in the EU and other international regulatory bodies, as applicable. Prepares clear, complete, and accurate documents that are logically constructed and comprehensive in content according to established templates and timelines. * Tracks submissions, correspondence, and commitments with health authorities and prepares responses and comments from regulatory agencies independently, proactively, in compliance with regulatory guidelines/requirements and according to established timelines. Communicates with Health Authorities and has a demonstrated ability to facilitate requests and anticipate appropriate next steps. * Develop and execute submission strategies based on ability to understand complex technical information, and provide guidance to existing and new cross-functional product core teams for new product development and various on-market enhancements/changes from product concept to placing on the market. Monitor progress on key project deliverables and provide status updates to management on a regular basis. * Collaborate with subject matter experts to ensure regulatory submissions requirements are being met and technical and scientific data are incorporated into regulatory submissions, and collaborate with partners and local liaisons for management of submissions in foreign countries and facilitate meetings with SMEs as needed to track progress. * Execute projects without supervision to align with and achieve the goals and timelines set by management * Makes decisions and influences stakeholders and teammates based on gained regulatory knowledge and experience, technical expertise and current regulatory compliance trends * Communicates moderately complex to complex regulatory topics to cross functional management, modify their communication style to fit the audience by embracing cultural differences and recognizing different knowledge levels. * Proactively research applicable regulations and guidance to the company's products and stay up to date on the current regulatory requirements and industry trends. Assess the impact of applicable regulations to the company's products and be able to identify mitigation plans, lead mitigation projects, and make decisions that will assist in reducing regulatory risk. * Review, provide regulatory input to, and approve various quality management system related documents including utilizing scientific concepts to critically review complex reports, validations, etc. to ensure regulatory requirements are being adequately addressed. * Provide support to lower level regulatory team members by sharing gained regulatory expertise, mentoring, reviewing submissions and/or training to company products and processes. * Assess changes to product for regulatory impact and include regulatory assessments in the established change control systems, as applicable. * Prepare regulatory documentation to support regulatory inspections/audits and to meet auditor/inspector requests * Identify process improvement initiatives and drives their successful execution * Provides regular status updates on projects to management. * Additional duties assigned as needed. Knowledge, Skills, and Abilities * This position requires a person with commitment to excellence, and ability to work in a fast-paced, technically skilled, team setting. * Demonstrated ability to independently coordinate and manage complex projects, prioritize multiple responsibilities and drive projects to completion * Demonstrated ability to strike a balance between independent work and team interaction, be a team player in a cross-functional team * Demonstrated interpersonal skills, with experience in interacting with and influencing people, building strong positive relationships * Demonstrated ability to identify issues, understand their urgency, escalate to management, and provide solutions. * Demonstrated understanding of IVD regulations, advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices. * Strong oral and written communication and presentation skills, capable of presenting and explaining complicated concepts to colleagues within the organization * Strong technical writing skills with ability to translate scientific information into technical documentation for submission to regulatory authorities * Demonstrates expert attention to detail with ability to identify areas of improvement and possible inconsistencies in documentation * Expert analytical and problem-solving skills, capable of identifying problems, determining root cause and providing solutions to management * Demonstrated ability to communicate with FDA and international customers (e.g., regulatory agencies, business partners, etc.) * Exceptional computer skills in Microsoft Office, Adobe, Excel * Knowledge in document management control systems (e.g. LSQM), change control systems (e.g. SAP), JIRA, required Education Bachelor's Degree required in the life sciences, engineering or similarly related field Experience 6 years of experience in a regulated environment with 4 years direct experience in Regulatory Affairs. IVD or Drug/Biologics Industry experience required. Equivalency Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. Occupational Demands Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Pay Scale The estimated pay scale for the Regulatory Affairs Specialist III role based in San Diego, CA, is $105,800 to $132,250 per year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! #LI-DC1 Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Grifols Diagnostic Solutions is seeking a Staff Systems Engineer to join our R&D Instrument Systems team. This position is located in San Diego, CA and is reporting to the Senior Manager, Systems and Validation. The Staff Systems Engineer shall be an experienced, cross-functional technical leader who will be responsible for supporting all phases of complex Nucleic Acid Testing in-vitro diagnostics (IVD) system development. As a technical lead they will work as a subject matter expert to solve complex technical challenges involving hardware, software consumables and the interaction with assay development. They will lead the Systems Engineering team in subsystem definition, integration, verification and subsystem failure investigations to ensure that critical sub-systems meet their individual performance, interface and system integration goals. In order to be successful in this role, we are looking for individuals to have at least 12 years' hands on experience developing electromechanical systems/subsystems for complex medical instruments, 7 years' experience as a Systems Engineer leading the architectural design and engineering of complex instruments, and 5 years of experience in requirements management. Primary Responsibilities for Role * Leads Systems Engineering efforts during the subsystem integration and verification testing phases to ensure that critical sub-systems meet their individual performance, interface and system integration goals and to ensure that the fully integrated system robustly meets its performance, safety and cost requirements * Lead Systems Engineers in translating system level requirements from cross functional teams into product architecture and system level design including partitioning functionality into sub-systems, creating specifications for each sub-system, and documenting the interface requirements among the sub-system * Resolve interface issues and have the ability to document theory of operations of complex medical product designs * Design, architecture, and development of electromechanical device with embedded software * Ensure compliance to the Product Development Process, Risk Management and Quality Systems * Deliver system engineering deliverables in a timely manner to support the execution of development projects including system requirements, hardware subsystem requirements, hardware, and software dFMEAs * Utilize a growth mindset to continuously improve our Systems Engineering capabilities * Work with verification and validation engineers to define test strategies for the development of verification plans and validation plans using requirement tracing methods * Ability to mentor Systems Engineers Additional Responsibilities * May be responsible for leading and/or managing other systems experts Knowledge, Skills, and Abilities * Experienced in System Engineering techniques such as model based system engineering * Advanced knowledge of standards including IEC 60601, ISO 14971, ISO 13485 and 62366 * Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise. * Demonstrated ability to translate high level product requirements into system and sub- system level specifications and designs System and hardware architecture definition and design * Ability to independently analyze and complex mechanical designs, circuitry and software using drawings, schematics, source code, technical education, and experience. * Excellent verbal and written communications skills. Demonstrated success in technical decision making and people management/leadership in a matrix environment. * Proven track record of developing complex products in a highly regulated environment * Requirements management using tools such as JAMA/JIRA a plus * Education * Minimum requirement: Bachelor's Degree in a technical discipline such as Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Electrical Engineering, Life Sciences or equivalent Experience * 12+ years of experience developing electromechanical systems/subsystems for complex medical instruments * 7+ years of experience as a Systems Engineer, leading the architectural design and systems engineering of complex instruments * 5+ years of experience in requirements management Equivalency Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. Occupational Demands Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequently walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Pay Scale The estimated pay scale for the Staff Systems Engineer role based in San Diego, California, is $161,554.30 to $201,943.45 per year. Additionally, the position is eligible to participate in up to 15% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! #LI-DC1 Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.