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Grifols jobs in Raleigh, NC - 155 jobs

  • Assistant/ Associate Biologist

    Grifols Sa 4.2company rating

    Grifols Sa job in Clayton, NC

    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. Hours: (6:00 PM - 6:00 AM) 12 hour * Week 1: Monday, Tuesday, (off Wednesday and Thursday), Friday, Saturday, Sunday * Week 2: (off Monday and Tuesday), Wednesday, Thursday, (off Friday, Saturday, and Sunday) Location: Clayton The incumbent is responsible for performing complex laboratory analysis of plasma and plasma products in a GMP laboratory. Responsibilities include sample accessioning, sample preparation, reagent preparation, testing, result calculation, as well as quality control of assays and equipment. The incumbent will also support assay validation, method transfer, reagent and control qualification, and laboratory maintenance activities as assigned. Must be comfortable working with infectious material on a daily bases. Person must be able to work in a biological safety cabinet and comfortable working with a microscope for several hours at a time. Candidates for the position must be proficient with using micropipettes and serological pipettes while making dilutions and serial dilutions. The person that fills this position must possess a keen attention to detail in that they will be performing complex tissue culture assays and maintaining cell lines. Tissue culture is preferred. Must be able to perform tasks by following SOP's and oral instructions. Must have precise, legible, and organized documentation skills. Candidates must also being willing to perform ones share of cleaning duties and housekeeping. This position is responsible for performing environmental monitoring of fill lines in B300 and SFF and also environmental monitoring of all classified production areas, including sampling of site utility systems. Environmental Assurance department must maintain adequate staffing to support all filling operations 24 hours per day, 7 days a week. In addition to routine environmental monitoring of the aseptic fill lines, this position is also responsible for executing the Quality Oversight program for the fill lines and also provides quality control approval of air flow visualizations conducted on site. This position is part of the budgeted staff necessary to complete this sampling and testing and to ensure that Clayton site environmental monitoring of the aseptic fill lines and other production areas and utility systems remain in a state of control. Current production levels require that multiple filling activities can occur during any shift and require EM staff to be available to support these activities in order to avoid production delays. Requirements: The Assistant level requires an AA or BS degree in medical technology/clinical laboratory science, or a BS degree in biology, chemistry or related field in addition to 6-12 months of applicable laboratory experience. A background in medical technology / clinical laboratory science is preferred, as is experience in a GLP / GMP laboratory. The Associate level requires an AA or BS degree in medical technology/clinical laboratory science, or a BS degree in biology, chemistry or related field in addition to 2 years of applicable laboratory experience. A background in medical technology / clinical laboratory science is preferred, as is experience in a GLP / GMP laboratory. Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. 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 and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures. 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 : NC-Clayton:USNC0002 - Clayton
    $36k-78k yearly est. 14d ago
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  • Intern - Marketing Campaign Specialist

    Grifols Sa 4.2company rating

    Grifols Sa job in Raleigh, NC

    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. Internship Start Date: Flexible - to be determined during the interview process Schedule: Part-time during the academic year, with transition to full-time over the summer Are you passionate about marketing strategy, project execution, and cross-functional collaboration? Join our dynamic Plasma Marketing team as a Marketing Campaign Execution Specialist Intern, where you'll gain hands-on experience managing omni-channel campaigns that drive donor growth and retention. This internship offers a unique opportunity to work across verticals, develop detailed project plans, and contribute to impactful marketing initiatives. If you're a highly organized, proactive student with a strong interest in marketing and project delivery, we invite you to bring your talents to a team that values innovation, efficiency, and results. Purpose & Responsibilities of Position: The Marketing Campaign Execution Specialist Intern will have the opportunity to learn more about how the Plasma Marketing team works across verticals to deliver powerful, omni-channel campaigns to market that drive donor growth and retention. In this role, the Marketing Campaign Execution Specialist Intern will: * Create detailed project plans, including end-to-end project tasks lists, that outline scope and timelines. * Support and oversee the execution of marketing campaigns, such as ad campaigns, donor promotions, and other content creation. * Create and manage project timelines, identify time-saving opportunities, and allocate resources effectively to ensure projects stay within constraints. * Act as the main point of contact for project stakeholders, provide regular status updates, and ensure everyone is aligned on project goals and progress. * Track project progress, identify and mitigate potential roadblocks, and evaluate the efficiency of campaign execution. * Work cross-functionally to collaborate with area subject matter experts and key stakeholders to improve business processes. Skills/Qualifications/Education Requirements: * Candidate must be currently enrolled in 4 year degree program pursuing Bachelor's degree in Business/Marketing or Scientific field (Biology/Chemistry preferred) as rising junior or senior OR currently accepted or enrolled in Master's or PhD program. * Candidate must currently have GPA of 3.0 or higher * Project Management familiarity, including strong organizational, prioritization, and time management skills. * Experience with Microsoft office. * Marketing strategy and execution knowledge is a plus. 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 : NC-RTP || NORTH AMERICA : USA : NC-Clayton || NORTH AMERICA : USA : NC-Raleigh:USNC0001 - RTP NC-Headquarters
    $37k-48k yearly est. 60d+ ago
  • Center Manager in Training - Relocation Required

    Biolife Plasma Services 4.0company rating

    Raleigh, NC job

    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** **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. After completing the program and obtaining a Plasma Center Operations Manager role, you'll relocate to one of BioLife's locations. **Our growth is your bright future.** Opportunities to grow as a leader are within your reach. With the incredible growth of 235+ 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:** + Relocation Required upon graduation/completion of Trainee Program. You will be able to choose which location you would like to apply to. + 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 **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_ \#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:** USA - MD - Virtual **U.S. Base Salary Range:** $80,000.00 - $110,000.00 The estimated salary range reflects an anticipated range for this position. The actual base salary 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 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._ **Locations** USA - MD - VirtualUSA - MD - Baltimore - West, USA - MD - Forestville, USA - MD - Riverdale Park, USA - MD - Salisbury **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time **Job Exempt** Yes
    $80k-110k yearly 48d ago
  • Manufacturing Associate (Downstream) - Day

    CSL Plasma 4.6company rating

    Holly Springs, NC job

    Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With the state-of-the-art manufacturing facility and an expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day. Reporting to the Supervisor or Sr. Lead, you will be a shop floor employee in manufacturing operations. You will provide (train in) the technical skill-sets necessary to manufacture high quality biologicals safely in a compliant, efficient, and cost-effective manner. Shift: Day Hours: 6AM - 6PM Follow 2-2-3 schedule Job level will be determined based on years of relevant experience to our processes and equipment Responsibilities Become trained on basic processes and equipment and serve as a hands-on resource in Production. Conduct all assigned activities in a safe and cGMP compliant manner. Cleaning, preparing, and sterilizing production equipment. Clean and disinfect production rooms. Assembly, set-up, and disassembly of production equipment. Complete process steps according to defined SOPs and BPRs. Document activities following cGMPs. Handle biologically and chemically hazardous goods. Work with process automation systems and electronic business systems (e.g, PAS, BAS, PLCs, LIMS, SAP, LiveLink.) Involved in Qualification and Validation activities. Identify process issues. Involved in completion of root cause investigations and CAPA. Work within a collaborative teamwork environment Experience High school diploma/GED required, with training and education from biotechnology coursework being a plus; Minimum of 1 year of transferrable skills and experience OR equivalent education, coursework or hands-on training in biomanufacturing related areas; experience in pharmaceutical, biotechnology, or sterile production environments. Basic knowledge of cGMP requirements preferred Experience with downstream purification operations and filtration, chromatography, or similar unit operations is an advantage Experience completing SOPs and documenting work Basic mechanical aptitude or knowledge of electronic / mechanical equipment preferred. Benefits: Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire. #LI-Onsite About CSL Seqirus CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at *************************** Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement. Watch our ‘On the Front Line' video to learn more about CSL Seqirus
    $24k-34k yearly est. Auto-Apply 1d ago
  • Leadership Management Program

    Biolife Plasma Services Careers 4.0company rating

    Durham, NC job

    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 (https://jobs. takeda. com/privacynotice) and Terms of Use (https://www. takeda. com/terms-and-conditions/) . 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. 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. After completing the program and obtaining a Plasma Center Operations Manager role, you'll relocate to one of BioLife's locations. Our growth is your bright future. Opportunities to grow as a leader are within your reach. With the incredible growth of 235+ + 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: * Relocation Required upon graduation/completion of Trainee Program. You will be able to choose which location you would like to apply to. * 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 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 #LI-Remote BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. W e are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - NC - Virtual U. S. Base Salary Range: $80,000. 00 - $110,000. 00 The estimated salary range reflects an anticipated range for this position. The actual base salary 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 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. Locations USA - NC - VirtualUSA - NC - Charlotte, USA - NC - Fayetteville - Morgan, USA - NC - Greensboro Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes
    $35k-49k yearly est. Auto-Apply 3d ago
  • Holly Springs Summer Communications Intern (Fixed Intern)

    CSL Plasma 4.6company rating

    Holly Springs, NC job

    Program Experience CSL's Internship Program is a hands-on experience that showcases the daily innovation and operations of a leading biotechnology company. Our environment is collaborative, global, and purpose-driven. The 12-week experience will immerse students in meaningful, thought-provoking projects that contribute to CSL's promise to save lives and protect the health of people around the world. In addition to making an impact, students will be developed personally and professionally while cultivating meaningful relationships. Main Responsibilities: This role will be located in Holly Springs, North Carolina. • Content Development: Produce a variety of content using copyrighting, graphics and/or video. This may include interviewing employees, taking pictures, writing articles, recording videos, and/or securing necessary internal approvals. Content will be used across multiple channels, including email, our internal communication channel, site screens, posters and more. o The majority of support will be provided for the Holly Springs site, but there may be requests to support regional or global initiatives. • Communication Production & Distribution: Produce and distribute sitewide email communications and site screens. Responsible for producing content for our internal communications channel. • Event Planning & Execution: Assist with preparation for and implementation of employee engagement initiatives and other special events. • Stay Informed: Stay up-to-date with the latest advancements in the field of communications and integrate new techniques where appropriate. • Professional Development: Engage in learning opportunities offered during the internship. Network with other members of the Holly Springs and Corporate and External Affairs teams to gain insights and career advice. Qualifications: • Enrolled in a 4-year university with progression toward an undergraduate degree in Communications, Journalism or related major • Demonstrates strong analytical and quantitative skills • Excellent communication and presentation skills • Able to manage multiple priorities, is a self-starter and keen on knowing when to work independently and collaboratively • Ability to work well with all levels of the organization • Demonstrates flexibility and acceptance of assignments and schedules • Enthusiasm to learn new tools & technologies • Maintains professional behavior About CSL Seqirus CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at *************************** Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement. Watch our ‘On the Front Line' video to learn more about CSL Seqirus
    $28k-38k yearly est. Auto-Apply 43d ago
  • Donor Center Technician I

    Octapharma Plasma 3.8company rating

    Raleigh, NC job

    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: Donor Center Technician This is What You'll Do: Ensures 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. Maintains high level of customer service and positive donor experience in line with company values and culture. Maintains 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. Maintains Donor Center equipment based on Standard Operating Procedures and applicable manufacturer instructions. Monitors donor conditions, employing techniques to ensure donor comfort, safety, and the quality of plasma product. Maintains Donor confidentiality based on company policy. Maintains 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. Cleans any blood or plasma spills and performs proper procedure for disposition of biohazardous waste. Performs other job-related tasks, as assigned. Donor Eligibility: Ensures that donor meets eligibility criteria based on Standard Operating Procedures. Performs donor vitals evaluation per Standard Operations Procedure. Performs finger stick for Microhematocrit and Total Protein determination. Registers applicant donors per Standard Operating Procedures. Plasma Collection: Sets up and prepares all equipment and disposable supplies for venipuncture and plasmapheresis procedures per standard operating procedures. Disconnects donor after plasmapheresis process is completed per standard operating procedures. Maintains proper ratio to ensure donor safety and quality of product. Operates 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. Handles 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. Prepares product and samples for shipments, per Standard Operating Procedures and federal transportation regulations. Monitors freezer and refrigerator temperatures and immediately inform appropriate personnel if equipment is not functioning properly. Record variance if applicable. JOB SPECIFICATIONS: High school diploma or equivalent (GED) 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. We're widely known and respected for our benefits and for leadership that is supportive and hands-on. Managers who truly want you to grow and excel. Formal training Outstanding plans for medical, dental, and vision insurance Health savings account (HSA) Flexible spending account (FSA) Tuition Reimbursement Employee assistance program (EAP) Wellness program 401k retirement plan Paid time off Company paid holidays Personal time 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. Interested? Learn more online and apply now at: octapharmaplasma.com And if you know someone else who'd be a great fit at Octapharma Plasma, Inc., please forward this posting along! INNER SATISFACTION. OUTSTANDING IMPACT.
    $28k-37k yearly est. 60d+ ago
  • Leadership Advancement Program

    Biolife Plasma Services Careers 4.0company rating

    Raleigh, NC job

    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 (https://jobs. takeda. com/privacynotice) and Terms of Use (https://www. takeda. com/terms-and-conditions/) . 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. 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. After completing the program and obtaining a Plasma Center Operations Manager role, you'll relocate to one of BioLife's locations. Our growth is your bright future. Opportunities to grow as a leader are within your reach. With the incredible growth of 235+ + 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: * Relocation Required upon graduation/completion of Trainee Program. You will be able to choose which location you would like to apply to. * 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 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 #LI-Remote BioLife Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. W e are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - NC - Virtual U. S. Base Salary Range: $80,000. 00 - $110,000. 00 The estimated salary range reflects an anticipated range for this position. The actual base salary 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 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. Locations USA - NC - VirtualUSA - NC - Charlotte, USA - NC - Fayetteville - Morgan, USA - NC - Greensboro Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes
    $80k-110k yearly Auto-Apply 3d ago
  • Validation Specialist

    Grifols Sa 4.2company rating

    Grifols Sa job in Raleigh, NC

    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. This is a Hybrid position based out of our RTP, NC Office. Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the evaluation, review and approval of validation and quality assurance/control documentation. * Assists in the development of cGMP operating procedures that relate to process, computer systems, and equipment validation. * Assures compliance with SOPs upon implementation. Investigates and proposes additional corrective actions as required. * Communicates with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues. * Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry: * Write test cases to validate critical control points, user requirements, and functional designs. * Execute test cases as needed. * Interacts with Donor Center and Field Quality/Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use. * Assists in analyzing validation data to ensure acceptance criteria are met. * Assists in writing validation summaries. * Ensure milestones and timelines are met on assigned projects. * Prepares validation reports for distribution. * Evaluates adequacy of corrective actions. * Participates in the evaluation of processes, systems, and individual center equipment needs and final approval process: * Prepares validation equipment for use at the Donor Center and for evaluation upon return. * Assists in identifying and determining actions to add, remove, and/or revalidate processes, systems, and equipment including evaluation of new/updated methodologies/applications/equipment and resolution of issues or problems with performance, transfer, or service. * Tracks and monitors process/system failures/events. Provides feedback to Donor Center management regarding requirements, results from data collected, and validation processes. * Tracks and monitors equipment calibration due dates and calibration failures/events. Provides feedback to Donor Center management regarding equipment calibration due dates, requirements, results from data collected, and validation processes. * Monitors and trends customer complaints and nonconformance related to equipment failures. Education & Experience * Bachelor's degree. * Typically requires 2 years of quality and validation experience in a cGMP and/or IT environment. * Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures. Excellent quantitative and analytical skills. Excellent oral and written communication skills. Strong critical thinking and problem solving skills. Ability to identify errors and provide corrective action. Ability to work with others in a team environment. Knowledge of Microsoft Office applications and computer applications used in the Donor Centers. Occupational Demands Form # 34: Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* and high levels of noise in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. May stand; bends and twists neck and waist for 2-4 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Repetitive foot movements. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. 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 and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures. EEO / Minorities/Disabled/Women/Veteran Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. #biomatusa #li-rl1 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 : NC-RTP:[[cust_building]]
    $65k-87k yearly est. 7d ago
  • Research Scientist

    Grifols Sa 4.2company rating

    Grifols Sa job in Raleigh, NC

    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. Summary: This position is in the Protein Discovery Department (Scientific Innovation Office) and will report to the In Vivo Science Manager. We are seeking highly motivated and hands-on experienced In Vivo Scientist. The individual within this position will work with other members of Protein Discovery to support and execute in vivo studies involving mice and rats. This is a high-visibility role requiring direct, daily hands-on work with mouse and rat dosing and monitoring, and data and samples collection from vivo studies. The successful candidate will be responsible for ordering animals and lab supplies, preparing and conducting in vivo studies in the lab, and collecting and organizing samples from executed in vivo studies before their transfer to internal or external research entities. Additional responsibilities include but are not limited to reviewing IACUC protocols, analyzing and presenting in vivo data internally, and externally, and supporting in vitro studies when the need arises. The position requires familiarity with IACUC regulations for animal research and excellent communication skills to work effectively with multiple teams within Protein Discovery. The ability to work in a fast-paced environment and adapt to changing priorities is essential. This role offers the opportunity to make a significant impact on our goal of developing new medicines for patients. Primary Responsibilities: * Ability to independently identify actions required to support departmental objectives. * Execute action plans independently, as part of a team, or as the lead for a departmental team. * Reports project activities to immediate supervisor and within group meetings, capable of presenting technical data at team meetings. * Independently prepares and edits procedures or technical reports, including data interpretation, suitable for regulatory submission. * Independently prepares and effectively communicates technical results in cross-functional team settings. * Independently applies sound scientific principles in development of solutions to complex technical problems. * Capable of mentoring/training junior staff in relevant principles and/or guidelines. * Independently designs, executes, and interprets results for scientifically complex experiments. * Capable of directing others in study execution. * Order animals and lab supplies necessary to execute in vivo studies. * Perform mouse and rat in vivo dosing, including tail vein injection, oral gavage, intraperitoneal and other IACUC-approved routes. * Set up in vivo study execution, prepare Excel spreadsheets for data collection and label tubes used to collect of an array of samples from terminal animals. * Collect in vivo data at the bench using Excel spreadsheets and post and maintain gained data into appropriate and designed locations (e.g., Protein Discovery SharePoint). * Carry out terminal surgery in rodents for blood and tissue collection in compliance with IACUC policies and regulations. Additional Responsibilities: * Maintains laboratory facilities in accordance with company policies and industrial best practices. * Provides support for research and developmental studies, clinical or commercial manufacturing as needed. * Identifies, implements, and qualifies, as necessary, equipment to meet industrial best practices or achieve compliance with regulatory expectations. Knowledge, Skills, & Abilities: * Ability to set and meet deadlines, multitask, and prioritize resources based on project needs * Capable of supervising a small team of junior scientists. * Must have excellent written and oral communication skills. * Demonstrates ability to apply diverse knowledge-base to novel areas. * Demonstrates ability to creatively apply scientific principles in problem solving in potentially novel areas. * Has considerable knowledge in professional field of specialization. * Proficient with the use of MS Office software. Minimum Requirements: * The position requires PhD plus 0-2 years experience, MS plus 2-4 years experience, or Bachelors plus 4-6 years experience. * Educational degrees must be relevant to position (e.g., Pharmacology, Biology, or Animal Science Biochemistry, Chemistry, or Toxicology) Occupational Demands: Work is performed in a clinical and/or a laboratory environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to chemicals. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits and bends neck for 4-6 hours per day. May stand and twist neck for 2-4 hours per day. Occasionally walks, bends and twists waist and squats. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Moderate lifting of 15-30lbs. with a maximum lift of 35 lbs. May reach above and below shoulder height. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. 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 : NC-RTP:USNC0003 - RTP NC-Research Building 85
    $60k-89k yearly est. 3d ago
  • Principal Quality Associate, QA Filling

    Grifols Sa 4.2company rating

    Grifols Sa job in Clayton, NC

    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. Hours: Monday to Friday - 8:00 am to 5:00 pm Principal Quality Associate The Principal Quality Associate, Quality Assurance Filling Business Unit, may be assigned duties and responsibilities within Quality Assurance supporting Filling. Specific duties will depend on the assignment and may include; review of manufacturing or testing records, preparation or review of failure investigations, product/raw material sampling and/or testing, sampling/testing/data analysis of environmental monitoring samples and data, auditing, data analysis for stability, etc. The incumbent is a professional with high technical competency who leads project or discipline teams. Can make quality decisions for the team. The employee influences the direction of complex projects and communicates with all levels of employees. Can identify continuous improvement opportunities and drive the change and assess impact to other areas of the business. The incumbent is recognized as an authority in multiple areas and provides leadership and guidance to others. The employee may be responsible for training other employees and is a fully qualified professional who requires minimal supervision. Serves as delegate to the manager. Primary responsibilities for the role ● Use expertise to advise and influence the technical decisions of business units. ● Responsible for development, maintenance and vitality of essential Grifols technologies. ● Interacts regularly with members of management and as needed with regulatory officials. ● Lead multi-disciplined project teams with highly technical objectives. Communicates project proposals to senior management and follows project through to successful completion. ● May mentor employees. ● Prepares, reviews, and in some cases approves SOP revisions, Change Control Requests, Incident Tracking System entries and investigation reports. ● Demonstrates high levels of values and integrity ● Can easily multi-task, prioritize and adapt to changing business needs ● Preparation/review/approval of regulatory documents ● Preparation of sections of the Annual Product Review as well as the overall APR ● Demonstrated ability to independently make sound quality decisions ● Demonstrated ability to influence decisions makers in other departments ● Review and approval of validations ● Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply. In addition to the duties described above the Principal Quality Associate, Quality Assurance may also perform the following duties: Responsibilities may include advanced roles (such as author, reviewer, approver, administrator or coordinator) in all quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews as well as provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions. Responsible for representing Quality manager at business unit meetings, and project meetings. Excellent communication skills (written and verbal). Demonstrated use of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines. Be able to work independently. This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. Requirements M10: BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 8 years relevant experience. A minimum of a BS/BA is required. 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 : NC-Clayton:USNC0002 - Clayton
    $48k-69k yearly est. 38d ago
  • Physical Records Management Specialist 1 or 2 / Sr.

    Grifols Sa 4.2company rating

    Grifols Sa job in Clayton, NC

    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. PRM Specialist 1: ● Assist in the coordination of the filing, storage, archival, retrieval, and retention of controlled documents and records at the Clayton site. ● Assist in maintaining Central Records Storage (CRS) system database and utilize to fulfill requests and catalog document submissions and attend all meetings ● Must interact with the various departments at the Clayton facility and assist in the coordination, storage, retrieval and transfer of documents on a daily basis. ● Support urgent requests (i.e. regulatory inspection/customer audit requests, information needed for batch release/certification, discrepancy investigation data, etc.). ● Assist in ensuring all documentation is archived systematically in accordance with established procedures and document all monthly and yearly metrics. ● Collaborate with other PRM specialists to ensure consistency and effective resolutions. ● Follow established procedures to process requests from the Clayton site through the PRM retrieval process and maintain the integrity of the Physical Records ● Assist in performing audit of archived records in accordance with established procedures to ensure document accountability. This is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. ● Must be able to work independently with minimal supervision and accuracy and manage multiple deadlines. ● Attention to detail and sense of urgency is required. ●This position requires climbing on ladders and platforms, and lifting boxes of up to fifty pounds over one's head. This position typically works under general supervision while performing assignments that are varied. PRM Specialist 2: * Coordinate daily activities associated with the maintenance and support of the Central Records Storage (CRS) area and conduct all necessary training of site-wide end. * Coordinate the filing, storage, archival, retrieval, and retention of controlled documents and records at the Clayton site. * Maintain CRS system database and utilize to fulfill requests and catalog document submissions and attend all meetings pertaining to CRS area. * Ensure all documentation is archived systematically in accordance with established procedures and document all monthly and yearly metrics. * Create and edit physical objects and mark physical objects for destruction. * Create new addresses and new containers for the warehouse. * Offer continuous improvement suggestions for efficient storage and retrieval processing. * Perform audit of archived records in accordance with established procedures to ensure document accountability and traceability. * Must be able to identify discrepancies or conflicts in storage and retrieval system that might impact the ability to retrieve packets and follow up with appropriate * Must be able to work independently with minimal supervision, accuracy, and manage multiple deadlines. * Attention to detail and sense of urgency is required. * Must be able to perform all responsibilities described in the PRM Specialist I . * Coordinate back up support as needed. * Support urgent requests (i.e. regulatory inspection/customer audit requests, information needed for batch release/certification, discrepancy investigation data, etc.). * Troubleshoot the validated PRM system as issues arise and offer solutions to problems. * This position requires climbing on ladders and platforms, and lifting boxes of up to fifty pounds over one's head. This position typically works under general supervision while performing assignments that are varied. PRM Specialist Sr.: * Plan, organize, and coordinate daily activities associated with the maintenance and support of the Central Records Storage (CRS) area and conduct all necessary training. * Coordinate the filing, storage, archival, retrieval, and retention of controlled documents and records at the Clayton site. * Maintain CRS system database and utilize to fulfill requests and catalog document submissions and attend all meetings pertaining to CRS area. * Ensure all documentation is archived systematically in accordance with established procedures and document all monthly and yearly metrics. * Perform audit of archived records in accordance with established procedures to ensure document accountability, traceability and / or other pre-established criteria are met. * Act as business administrator to create folders and assign users to a group. * Create new containers for the warehouse. * Offer continuous improvement suggestions for efficient storage and retrieval processing. * Must be able to identify discrepancies or conflicts in storage and retrieval system that might impact the ability to retrieve packets and follow up with appropriate personnel * Must be able to work independently with minimal supervision, accuracy, and manage multiple deadlines. * Attention to detail and sense of urgency is required. * Support urgent requests (i.e. regulatory inspection/customer audit requests, information needed for batch release/certification, discrepancy investigation data, etc.). * Consults with management and offers solutions to inefficiencies/problems and makes continuous improvement suggestions. * Troubleshoot PRM system errors and coordinate fixes with IT and/or end users. * Must be able to perform all responsibilities described in the PRM Specialist I and II job descriptions. * This position requires climbing on ladders and platforms, and lifting boxes of up to fifty pounds over one's head. This position typically works under general supervision while performing assignments that are varied. 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 : NC-Clayton:USNC0002 - Clayton
    $34k-47k yearly est. 43d ago
  • Phlebotomist II

    Octapharma Plasma 3.8company rating

    Rocky Mount, NC job

    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: Phlebotomist II This is What You'll Do: * Ensures 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. * Maintains high level of customer service and positive donor experience in line with company values and culture. * Maintains cleanliness of work area to ensure a clean and professional environment. * Reviews and confirms donor identification and maintains donor confidentiality per Standard Operating Procedures. * Sets up and prepares all equipment and disposable supplies for venipuncture and plasmapheresis procedure. * Labels and ensures each unit and samples are labeled accurately. * Execute venipunctures and plasma collection, maintaining the highest standards of quality and safety. * Operates the automated plasmapheresis machines, including response and evaluation of all machine alarms and alerts, donor adverse events, document exceptions, etc. * Monitor donor conditions, employing techniques to ensure donor comfort, safety, and the quality of plasma product. * Maintains proper ratio to ensure donor safety and to quality of product. * Disconnects donors and handles the disposal of biohazardous waste and contaminated equipment, including cleaning spills and following safety protocols. * Performs daily, weekly, and monthly calibration/maintenance of automated plasmapheresis machines and removes and/or replaces equipment from service, if needed. * Reports all unsafe situations and conditions to management. * Maintains/stocks adequate inventory and replenish supplies on plasma carts. * Responsible for mentoring Phlebotomist I and may be assigned to drive training efficiencies to ensure timeliness and compliance and may be assigned as a Designated Trainer. * Responsible for troubleshooting machine alarms/alerts and perform QCs routinely (defined as daily/monthly). * Partners with Quality Assurance on overall Donor Floor performance (favorable performance observations, CAPA implementations and continuous improvement initiatives). * Assists with storage room organization and performs assigned tasks following the First In, First Out (FIFO) method. * Performs other job-related tasks as assigned. This is What It Takes: * High school diploma, or equivalent (GED) required * Any specific certification or licensing based on State requirements. * Minimum three (3) months' experience in a medical or health care environment or equivalent combination of education and experience preferred. * Must have completed documentation of training appropriate for duties, prior to performing duties independently. * Ability to speak, read, write (legibly and accurately), and understand English required. * Strong customer service skills required. * Ability to understand and follow written and verbal protocol required. * Basic computer knowledge and skills required. * Able to make accurate and complete documentation. * Ability to read and interpret documents, such as safety regulations, operating and maintenance instructions and procedure manuals required. * Ability to function effectively in a fast-paced environment with frequent interruptions. * Demonstrated consistency and reliability (good attendance, punctual, apply full effort throughout shift, flexibility with assigned schedule) required. * Ability to work daytime and evening hours, weekends, holidays, and extended shifts on a frequent basis required. * Ability to perform venipunctures required. * Effective communication skills required. * Employee possesses enhanced collaboration and adaptability skills. Do Satisfying Work. Earn Real Rewards and Benefits. We're widely known and respected for our benefits and for leadership that is supportive and hands-on. Managers who truly want you to grow and excel. * Formal training * Outstanding plans for medical, dental, and vision insurance * Health savings account (HSA) * Flexible spending account (FSA) * Tuition Reimbursement * Employee assistance program (EAP) * Wellness program * 401k retirement plan * Paid time off * Company paid holidays * Personal time 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. Interested? Learn more online and apply now at: octapharmaplasma.com And if you know someone else who'd be a great fit at Octapharma Plasma, Inc., please forward this posting along! INNER SATISFACTION. OUTSTANDING IMPACT.
    $27k-36k yearly est. 60d+ ago
  • Clinical Research Associate 3

    Grifols Sa 4.2company rating

    Grifols Sa job in Raleigh, NC

    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. The Clinical Research Associate assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Ensures coordination of an accelerated study start-up including pre-study visits, initiation, interim, and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study. Primary responsibilities include: * Tracking study specific tasks and progress of the trial. * Performing regulatory document review and approval for IP release. * Assisting in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings). * Conducting monitor training. * Performing monitoring/co-monitoring activities for site initiation visits, interim site monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies. * Understanding and implementing processes for distribution and tracking of SAE's, safety documentation, and pregnancies. Monitors compliance of these processes. * Collaborating with data management to resolve queries. * Facilitating investigator site payments, as applicable. * Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation. * Assisting in evaluation of vendor performance during conduct of the study. * Acquiring a basic knowledge of the therapeutic area and product. * Obtaining a complete understanding of all trial-related documents and operational procedures. * Gaining exposure/participates in CRF development, IVRS set-up, central lab set-up, and other vendor selection processes. * Maintaining clinical trial management system (CTMS) information pertaining to the study as applicable * Assisting with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation). * Reviewing and tracking study documents, including: project files both electronically and in the Trial Master File and Project Status Reports. * Preparing accurate and complete meeting minutes for various meetings. * Communicating and interacting with relevant study personnel, including: develops and maintains collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to study manage; troubleshoots and follows up on study progress; and, reviews report data for completeness and accuracy. * Assists with effective and timely audit/inspection responses. For studies monitored in house by Grifols, additional responsibilities may include: * Identifies/screens/qualifies investigators through feasibility questionnaires and pre-study visits. * Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up. * Conducts/oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine protocol and regulatory compliance. * Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity. * Reconciles clinical supplies and drug accountability records at study sites. * Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required. * Reviews, clarifies, and obtains, data changes via query resolutions with site personnel. * Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to accurately and completely document site status and activities. Additional responsibilities: Leads the activities of the CRA team to meet the study objectives. Identifies and addresses weaknesses in individual or team performance. Assists study manager in overall study management. Monitors and/or co-monitors as required with CRO and CRA staff to insure study integrity and compliance. Develops ICF templates and reviews study specific ICF(s). Participates in CRF development and completion. Reviews monitoring reports and QA reports from site visits. Manages clinical study set-up and follow-up study activities through tracking and review. Assists in the development of the clinical risk management plan. Develops, implements, and maintains monitoring plan for studies run internally. Coordinates and presents at investigator meetings, kick-off meetings, etc. Interacts as functional lead with data management, safety, regulatory personnel, and other functional groups. Leads team members in reviewing data listings in reviewing data listings and writing queries. Tracks and manages the distribution of study drug and clinical supplies. Contributes to development of site budget. Knowledge, Skills, and Abilities: Excellent knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs. Excellent knowledge of therapeutic area assigned. Excellent knowledge of ICH/GCP Guidelines and EDC process. Strong verbal and written communication skills. Ability to train others in using MS Office Suite, Impact, and EDC systems. Ability to meet deadlines, multitask, and prioritize based on study needs. Ability to make sound decisions based on available information. Ability to establish rapport with site personnel/ colleagues. Ability to work both in a team and independently. Ability to facilitate team meetings and teleconferences. Ability to present at internal study team meeting(s). Ability to train and mentor junior CRAs. Ability to seek new learning opportunities within and outside of the assigned project. Ability and willingness to travel. Requirements: * Associate's degree in a life science field required. Bachelor's degree in a life science field preferred. * Typically requires 5 years of experience in clinical research, including a minimum of 2 years field monitoring experience and 3 years in lead CRA role. * 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 and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. 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. 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 : NC-RTP:[[cust_building]]
    $55k-90k yearly est. 60d+ ago
  • Assistant Biologist / Associate Biologist

    Grifols Sa 4.2company rating

    Grifols Sa job in Clayton, NC

    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. Shift: 12 hour (rotating) day shift Week 1 - Mon, Tues, Friday & Saturday (6:00 am-6:00 pm) Week 2 - Sun, Wed & Thur (6:00 am-6:00 pm) Location: Clayton This position is responsible for performing environmental monitoring on classified areas and utility systems. Depending on area of assignment, responsibilities will include the collecting and/or testing of environmental, utility, raw material, or validation samples utilizing test methods that are specific to the assigned laboratory. Candidates must be able to follow the requirements of Grifols, Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP) and complete work in a safe, accurate, and efficient manner. Responsibilities will also include performing non-routine duties, housekeeping duties, etc. as well as participating in projects such as standard and control preparations, method validations, comparison studies, etc. Requirements: The Assistant level requires an AA or BS degree in medical technology/clinical laboratory science, or a BS degree in biology, chemistry, or related field in addition to 6-12 months of applicable laboratory experience. A background in medical technology / clinical laboratory science is preferred, as is experience in a GLP / GMP laboratory The Associate level requires an AA or BS degree in medical technology/clinical laboratory science, or a BS degree in biology, chemistry or related field in addition to 2 years of applicable laboratory experience. A background in medical technology / clinical laboratory science is preferred, as is experience in a GLP / GMP laboratory. Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. 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 and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures. Location: NORTH AMERICA : USA : NC-Clayton:[[cust_building]]
    $49k-71k yearly est. 14d ago
  • Electrical and Instrumentation Engineer - Staff/Principal

    Grifols Sa 4.2company rating

    Grifols Sa job in Clayton, NC

    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. Summary We are seeking a Electrical & Instrumentation Engineer to play a critical role in delivering reliable, compliant, and innovative solutions for complex capital projects. This position offers the opportunity to work across all phases of projects from planning and design to procurement, construction, and start-up while collaborating with multidisciplinary teams to make a global impact. Primary Responsibilities In this role, you will: * Lead Project Scope: Manage assigned scope, cost, and schedule for all responsibilities. * Design and Develop: Create low-voltage power distribution systems and motor control designs. * Instrumentation Expertise: Select and size instrumentation based on P&IDs and site standards. * Control Systems: Choose control system hardware aligned with site requirements. * Technical Documentation: Prepare equipment specifications, bid packages, and detailed schematics including single lines, motor control diagrams, and loop sheets. * Vendor and Contractor Oversight: Perform vendor evaluations, monitor progress, attend factory acceptance testing, and supervise contractors during construction to ensure safety, quality, and schedule adherence. * Commissioning and Turnover: Execute equipment start-up, develop commissioning protocols, and prepare turnover packages. * Compliance and Standards: Size electrical components per NFPA 70 and adhere to Good Manufacturing Practices (GxP), including compliance, change control, quality oversight, and validation. * Collaboration: Coordinate with other disciplines throughout design, construction, and start-up phases. * Configuration: Provide initial settings for VFDs and motor starters. * Communication and Problem-Solving: Deliver clear verbal and written communication, demonstrate strong problem-solving skills, and foster a collaborative team environment. Education and Experience Requirements Based on Level Staff Engineer Level: Minimum Education: Bachelor's Degree in Engineering or related field. Professional registration and/or certifications as appropriate. Minimum of 5 years of related experience. Experience in Biotech, Pharmaceutical, or Chemical Industry preferred. Principal Engineer Level: Minimum Education: Bachelor's Degree in Engineering or related field. Professional registration and/or certifications as appropriate. Minimum of 8 years of experience. Experience in Biotech, Pharmaceutical, or Chemical Industry preferred. Additional Requirements PE license in NC preferred. Occasional international travel required (e.g., Spain, Canada). Occupational Demands: Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments, and gloves. Frequently sits for 4-6 hours per day. Stands for 2-4 hours per day. Frequent movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Occasionally bends and twists neck and waist. Frequent foot movements. Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. 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 and written words and sentences. Frequently performs routine tasks by following a set of written or oral instructions/procedures. 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, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws. Location: NORTH AMERICA : USA : NC-Clayton:[[cust_building]]
    $62k-85k yearly est. 60d+ ago
  • Manager, Quality Assurance (2nd shift)

    Biomat USA, Inc. 4.2company rating

    Clayton, NC job

    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. **This position is 100% on-site at our Clayton, NC Facility.** **Hours: 2nd Shift (10 hour) Monday - Thursday 1:30pm - 12:00am Summary:** The Quality Assurance (QA) Manager assures consistent quality of production by developing and enforcing good manufacturing practices (cGMP) systems to ensure overall compliance with operating procedures, regulatory requirements and reports the facility compliance status to Operational and Quality management. This position has primary responsibility for the quality acceptance and release of plasma product shipments and manages the daily activities of the Plasma Logistic Center (PLC) quality assurance staff. **Primary Responsibilities:** + Manages the daily activities of the PLC quality assurance staff and ensures that required activities related to the receipt, storage, clearing, processing of lookback alerts, quarantine of unsuitable units, and release of source plasma for further manufacture or sales. + Responsible for the QA release of plasma from PLC and verifies that all shipment contents meet standard operating procedures, regulatory and customer requirements prior to release. + Maintains the PLC deviation management system to notify plasma collection centers (internal and external) of nonconformities noted during the plasma receipt and plasma processing. + Investigates and documents deviations noted as a result of routine compliance reviews, internal and external audits and customer complaints. + Participates in the writing and revision of policies and procedures related to the PLC. + Monitors the PLC in order to maintain compliance with all applicable regulations. + Hires quality assurance staff and implements training programs, career advancement objectives for quality assurance staff, performs performance appraisals and enacts corrective actions as needed to and including termination. + Meet quality assurance and company financial objectives by monitoring department costs. + To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. **Knowledge, Skills, and Abilities:** + Strong analytical, organizational and interpersonal skills. + Extensive knowledge of cGMPs as specified in the CFR/USP and EP Pharmacopeia/ICH and ISO Guidelines. + Excellent written/verbal/leadership skills. + Must be able to make sound decisions that may affect the quality purity or efficacy or a drug product. + Anticipates and identifies problems; analyzes situations; consider alternatives; monitor and evaluates results in a systematic manner. + Displays a commitment to quality in terms of people, product and processes. + Computer literate, with experience in use of Microsoft applications. **Education and Experience:** + BS degree in Biology, Chemistry or related Science or Engineering. + Typically requires a minimum of 5 years of Quality Assurance related experience and 3 years working in pharmaceuticals. Project or technical leadership experience required. Supervisory or management experience preferred. + 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. Occupation Demands: Ability to read and review documents for up to four (4) hours at a time. Ability to stand for extended periods of time - up to four (4) hours at a time. Ability to lift, tug, pull up to fifty (50) pounds. Ability to travel via automobile and/or airplane. This 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.** **Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton** Learn more about Grifols (************************************** **Req ID:** 538521 **Type:** Regular Full-Time **Job Category:** GENERAL MANAGEMENT
    $77k-110k yearly est. 9d ago
  • Sr. Regulatory Affairs Specialist II/Manager

    Grifols Sa 4.2company rating

    Grifols Sa job in Clayton, NC

    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. Summary: Implement worldwide regulatory product registration strategies, prepare complex registration dossiers, establish and maintain tracking of product registrations to determine what products can be shipped to intended markets in accordance with business plan with a specific focus on labeling, labeling requirements, and implementation. Coordinate and submit all regulatory documentation for establishment of new / changed local market authorization holders and distributors. Primary Responsibilities: * Act as Regulatory Affairs authority for key product registrations with a main focus in labeling and labeling related activities. * Analyze and determine worldwide product registration requirements for specific assigned products and regions. Implement worldwide regulatory registration strategy, communicate and negotiate with local market authorization holders/ distributors / regulatory authorities the information required and prepare regulatory submissions to be used worldwide for all marketed products. * Prepare complex registration dossiers, local application forms; negotiate documentation required for worldwide markets which may include product custom clearance documentation and coordinate with International Customer Service, Quality and Commercial preparation of required documentation in accordance with local requirements. * Prepare responses to regulatory agency inquiries. * Coordinate with local authorities and Quality standards and controls required for product registration testing. * Represent the regulatory function in communication with outside companies, customers and regulatory authorities. Responsibilities may include preparation and presentation (if required) to regulatory authorities. (e.g. labeling specific projects). * Represent the regulatory function on project teams as related to worldwide product registrations. Provide information that is presented to, for example, the Peer Review Committee, the Site Leadership Team and the Quality Management Review to enable informed decisions. * Collaborate with all disciplines to assure appropriate testing and documentation are generated for regulatory submissions and routine import documentation. Prepare personnel from affiliates or third parties for meetings with regulatory authorities. * Coordinate and interact with domestic and international regulatory counterparts to obtain input regarding regulatory considerations and decisions to formulate regulatory strategy for changes to products/facilities/equipment with an impact on product labeling. * Request and obtain all required FDA export documentation required for registration and routine product shipments. * Evaluate impact of new labeling regulatory requirements as well as evaluate changes to existing product labeling on assigned projects and products and inform other departments as necessary. * Maintain worldwide product registration status and distribute routine updates to commercial, sales and Quality to determine where registered products can be marketed. * Mentor and support the professional development of staff. * Perform other duties as required. Knowledge, Skills, and Abilities: * Ability to prioritize and initiate contacts essential to labeling submission preparation. * Ability to work independently and initiate contacts essential to create labeling components for submission preparation while ensure technical information is accurate. * Knowledge of product and labeling history to maintain consistency within a product line and within the product portfolio labeling. * Ability to clearly communicate verbally and in writing with internal and external contacts that may include industry representatives, affiliates, third parties and regulatory authorities in various countries. * Ability to work with management of other Grifols departments to achieve common business goals as well as regulatory objectives. * Ability to review a document, including labeling, in detail to ensure accuracy based on regulatory requirements, and to ensure the use of the appropriate forms, format, content, and authorized signatures. * Ability to effectively use Microsoft Office (particularly Word and Excel) to create, edit, and format documents * Ability to work with other computer systems for filing supplements and reports. * Ability to interpret and effectively communicate regulatory requirements internally as well as to distributors/affiliates with a specific focus in labeling. * Ability to successfully interact with external contacts which may include worldwide distributors / Grifols affiliates / regulatory agencies through professional, articulate, and courteous conversations and clear, concise written communications. * Ability to meet statutory deadlines to ensure compliance, as well as business timelines to accomplish company objectives. Preferred Background: * Advanced degree with clinical experience * Experience working on global labeling initiatives and submissions * Familiarity with electronic labeling systems and regulatory publishing tools * Demonstrated leadership in cross-functional team settings Minimum Requirements: Sr. Specialist II * Bachelor's degree in relevant discipline, or equivalent work experience industry regulatory experience. * Minimum 5 years of related technical and/or regulatory experience in pharmaceutical industry or an equivalent combination of education and experience. * Experience with biological products related to but not limited to facilities, validation, environmental monitoring, cGMP manufacturing, QA/QC for biological products, compliance and/or regulatory is required. * Excellent written and verbal communication skills. * Knowledge of applicable laws and regulations Manager * Bachelor's degree in relevant discipline, or equivalent work experience industry regulatory experience. * 6 to 7 years related technical and/or regulatory experience in pharmaceutical industry, or an equivalent combination of education and experience. * Extensive knowledge of applicable worldwide regulatory product registrations laws and regulations. * Excellent verbal and written communication skills 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 : NC-Clayton:USNC0002 - Clayton
    $49k-69k yearly est. 49d ago
  • Assistant Chemist / Associate Chemist

    Grifols Shared Services North America, Inc. 4.2company rating

    Grifols Shared Services North America, Inc. job in Clayton, NC

    Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions. **This is a 2nd shift position; Hours are 3:00pm - 11:30pm | Monday - Friday** **Assistant/Associate Chemist** Performs chemical testing of moderate to advanced complexity within a Quality Control Laboratory in a safe, accurate, and efficient manner following established written procedures while maintaining complete and accurate records of the work and results. This testing is required for the release of raw materials, in-process materials, and final containers. This position will primary support the in-process testing groups. The in-process group is responsible for completing real time testing to directly support the manufacturing process. **Primary Responsibilities:** ● Conducts various routine and non-routine chemical testing (assays) according to procedure. Tests consists of both manual (preparing dilutions which are analyzed spectrophotometrically) and automated (chromatography, atomic absorption spectrophotometry, electrophoresis, etc.) assays. Instruments utilized in the laboratory include basic meters (pH meter, conductivity meters, chloride meters, etc.), Atomic Absorption Spectrophotometers, chromatography equipment (HPLC, GC and IC, which utilize Chromeleon and Waters software), electrophoresis (includes standard electrophoresis, capillary zone electrophoresis and agarose membrane electrophoresis) and moisture titrators (Karl Fischer). ● Follows the requirements of Grifols' Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP). ● Maintains complete and accurate records of work performed and test results. ● Calibrates equipment and performs equipment maintenance ● Performs non-routine duties, housekeeping duties, etc. as assigned ● Learns and follows the methods and the techniques of the chemical tests to be performed. This learning is a continuation of learning that occurred as Assistant Chemist. ● Performs assigned testing in an accurate and efficient manner. Keeps complete and accurate records of the work performed and results. ● Trains Assistant Chemists and other Associate Chemists in areas of this Associate Chemist's knowledge, experience, and expertise. ● May coordinate laboratory activities in the absence of the Laboratory Supervisor. ● Remains compliant with all applicable safety, environmental, regulatory, and training standards, goals, and objectives ● Supports development, validation, and revision of laboratory procedures as assigned ● Conducts all work with a focus on safety, quality, and timely throughput **Additional Responsibilities:** An Assistant Chemist participates in Quality Control studies (blind testing series, validation protocols, precision and accuracy studies) of the tests for which they are trained. Remains compliant with all applicable safety, environmental, regulatory, and training standards, goals, and objectives. Conducts all work with a focus on safety, quality, and timely throughput **Knowledge, Skills, Abilities:** The Assistant Chemist is expected to progress to a performance level requiring less direct supervision (either by the Laboratory Supervisor or the assigned Associate Chemist trainer). The Assistant Chemist position requires basic time/work management skills as the incumbent is expected to complete work assignments accurately and efficiently with only infrequent review by the Lab Supervisor. The Assistant Chemist is expected to have basic verbal and written communication skills. The Assistant Chemist is expected to maintain a professional relationship with peers, to be an effective member of the lab "team" working toward common goals, and to work well in a situation in which most equipment necessary to complete one's daily assignment is also used by others. **Education/Experience:** Assistant Chemist - An associate degree in chemistry or a related curriculum and a minimum of six months of applicable laboratory experience or a BS/BA degree in chemistry or related curriculum is required. Associate Chemist - The Associate Chemist position is normally a progression from the Assistant Chemist position in the Quality Assurance Chemistry Labs. Therefore, the Associate Chemist position also requires knowledge equivalent to a minimum of (2) two years of college level chemistry courses (one year of general chemistry course(s) with associated laboratory work, one or more courses in analytical quantitative chemistry with associated laboratory work, and some other chemistry course(s) with associated laboratory work). While the content of the course work specified above is generally applicable to the Associate Chemist position, the associated laboratory experience is more specifically applicable to the position's work assignments Work is performed in an office and a laboratory/manufacturing environment or warehouse. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. 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 and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures. ***Employee Referral Bonus Eligible*** **Location:** **NORTH AMERICA : USA : NC-Clayton** **:** **[[cust_building]]** Learn more about Grifols (************************************************* **Req ID:** 537861 **Type:** Regular Full-Time **Job Category:** OPERATIONAL TECHNICAL AREA
    $44k-68k yearly est. 9d ago
  • Intern - Engineering Capital Projects

    Grifols Sa 4.2company rating

    Grifols Sa job in Clayton, NC

    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. Summary: * As part of the capital projects engineering team, for new or remodeled manufacturing facilities for plasma-based processes, intern would assist in the design, budget, procurement, fabrication and commissioning of hygienic equipment/facilities. * This job is located at the Grifols Clayton, NC site and is NOT remote. Primary Responsibilities/ Tasks: Responsibilities would include any or all of the following: * As part of the process skid fabrication shop, for simple process equipment, design using 3D CAD software, quote, supervise fabrication, and document. Learn and participate in welding. * As part of the CAD team, assist in implementing Plant3D system at the Clayton site. * As part of a commissioning team, complete commissioning activities such as verifying piping and instrument diagrams, mechanical drawings and prepare/review turnover packages in preparation for validation. Enter and track turnover packages into the ACC docs system. * The engineering intern also would follow up on receiving items ordered, ship dates, completing goods receipts, tracking completion of tasks and schedules. * If a summer maintenance turnaround is planned, assist in preparing for construction. Requirements: * Currently pursuing Associates, Bachelors or Masters degrees in Biomedical, Mechanical, Chemical or Industrial Engineering * Skilled at organizing information in Excel spreadsheets * Willing to work across multiple disciplines such as process, utilities and HVAC. * Prefer candidates with classes in biotechnology or hygienic systems. * Prefer candidates with classes in AutoCAD, Plant3D, SolidWorks or 3D design. * Prefer a candidate with understanding of welding. * Prefer candidates with classes in protein processing. * Candidates will be asked to bring examples of college projects to the interview. * GPA at least 3.0. 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 : NC-Clayton:USNC0002 - Clayton
    $33k-41k yearly est. 3d ago

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