CSL Plasma jobs in Durham, NC

2026 Communications Intern Hiring Manager Name: Jennifer Bailey CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL - including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor - provides lifesaving products to patients in more than 100 countries and employs 29,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. 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 experience immerses 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 news site, 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.. • 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 CSL will provide equal employment opportunity for all persons without discrimination on the basis of membership in a legally protected class, including race, color, religion, national origin, gender, age, veteran status, or handicap/disability. CSL is committed to ensuring that diversity and inclusion are a part of our everyday business. 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

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._ 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 - 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

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: 12 Hour Shift ; 3:00 PM- 3:00 AM ; rotating shift; (Training will take place on 1st shift the first 3-6 months) Week 1: M, T, F, Sat. Week 2: Su., W, Th. Location: Clayton Hiring Manager: Jason Sikes 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 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:USNC0002 - Clayton Learn more about Grifols

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. Primary Responsibilities: * Participate in the development and review of the Clinical SOPs, Regulatory documents and Study Plans * Participate in the Clinical SOPs periodic reviews as well as in the creation of new procedures * Participate in the study plans reviews * Participate in the review of Regulatory Documents (Clinical Study Protocol, Investigators Brochure, Informed Consent Form, Clinica Study Report) * Provide quality oversight on the conduct of the clinical studies * Perform periodic quality reviews of the critical clinical procedures on the different clinical studies * Interact with Drug Development department to provide guidance and consultancy to resolve compliance issues * Coordinate the management of study, internal and vendor deviations * Participate in the review of critical protocol deviations and Serious Breaches * Participate in project team internal meetings providing information about quality metrics of studies * Collaborate in the development of the Quality Risk Management Assessment of the different clinical studies * Initiate the Quality Risk Assessment for every clinical study * Qualification and periodic assessment of clinical and pharmacovigilance vendors participating in the clinical studies * Perform a quality assessment (including a risk assessment) of all the vendors selected as candidates to participate in the clinical studies * Qualify the clinical vendors before their participation in the clinical studies and re-qualify them when applicable * Perform an annual assessment of the performance and compliance of the vendors participating in the clinical studies Requirements: * Life Sciences Degree. * A minimum of 5 years in a similar role or provide experience in Quality and Clinical Trials. * Ability and willingness to travel. * Ability to work both in a team and independently. * Ability to meet deadlines, multitasks, and prioritize based on study needs. * Ability to works on assignments with a diverse scope. * Ability to work with a very limited direct supervision. * Advanced knowledge of ICH/GCP Guideline. * Advanced knowledge of electronic data capture (EDC) systems. * Advanced knowledge of medical terminology. * Advanced knowledge of the therapeutic areas assigned. * Routinely demonstrates mastery of technical skills Occupational Demands Form: 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]]

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. Packaging Tech 1 / Packaging Tech 2 Hours: **2nd** **shift** ( **Mon - Thurs / 3:30 pm - 2:00 am)** **Summary:** The Packaging Technician 1 & 2 responsibilities are to detect and identify defect trends during the inspection of manufactured products. Accurately inspecting and selecting product samples for both routine and non-routine quality and stability testing. Performing labeling activities and to verify product and diluent vial labeling used in the packaging of biological products for accuracy. The Packaging Technician 2 responsibilities are to detect and identify defect trends during the inspection of manufactured products. Accurately inspecting and selecting product samples for both routine and non-routine quality and stability testing. Performing labeling activities and to verify product and diluent vial labeling used in the packaging of biological products for accuracy. **Packaging Tech 1:** + Perform paced inspections of final container products for multiple categories of defects. + Document job tasks as required on the Batch Production Record (BPR), Standard Operating Procedure (SOP) document or other acceptable form(s). + Perform housekeeping tasks and maintain department housekeeping at an optimal level. + Adhere to all company safety and cGMP policies and practices. + Meet and maintain visual inspection recertification requirements through knowledge of the PDA Lexicon for glass defects and the in-house training and certification standards. + Other duties as assigned. Additional Packaging Technician duties: Set-up, operate and troubleshoot various packaging equipment; Manually package products; Inspect packaged and pre-packaged products for possible defects; Conduct an accurate count of pre and post packaged products; May off load and load products from cages, carts, and boxes; and May operate material handling equipment such as pallet jacks, forklifts, etc. In Grade Salary Adjustment Requirements: Set-up and operate multiple label verification vision systems on vial labelers and cartoners. Set-up and operate multiple vial labelers, vial cartoners, shrink banding machines and other equipment related to final container labeling. Conduct periodic challenges for the various packaging systems. **Knowledge Skills and Abilities:** Able to work effectively as a member of a team. Must pass annual vision testing for near vision and colorblindness. Must be able to pass initial visual inspection certification within 90 days of hire date. Able to identify product defects in accordance with the PDA Lexicon for glass defects and other applicable SOPs. Must be capable of maintaining continuous and concentrated focus on assigned tasks during packaging activities. **Requirements: Tech 1 - Education/Experience: High School Diploma. Packaging Operator/Inspector experience preferred** **Packaging Tech 2:** + Perform duties associated with the Packaging Tech I level + Troubleshoot, maintain and do changeover for Packaging equipment. + Qualified to set up and operate Packaging equipment (e.g. serialization equipment , vial labelers, cartoners, shrinkbanding machines, etc.) + Deliver samples to various Quality Laboratories for required testing. + Operate a computer to review and /or enter data into a variety of systems including but not limited to LIMS, SAP, etc + Must possess and maintain knowledge of various product specifications in order to ensure that correct components are used. + Evaluate the cause of rejected labeling and document findings according to SOPs. **Knowledge Skills and Abilities:** Able to work effectively as a member of a team. Must pass annual vision testing for near vision and colorblindness. Must be able to pass initial visual inspection certification within 90 days of hire date. Able to identify product defects in accordance with the PDA Lexicon for glass defects and other applicable SOPs. Must be capable of maintaining continuous and concentrated focus on assigned tasks during packaging activities. **Requirements: Tech 2 -** Education: HS Diploma. Experience: 1-year Packaging Inspector/Label Verification Tech experience preferably obtained in a pharmaceutical or biotech environment. Work is performed in a manufacturing environment with rotating shifts. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to chemicals, electrical manufacturing equipment, hand tools and moving machinery. Exposure to high levels of noise and to extreme cold below 32*. Exposure to office electrical equipment. Personal protective equipment required such as protective eyewear, safety shoes, gloves and garments. Occasionally enters into confined spaces requiring squatting, kneeling or climbing. Work is performed standing for 6-8 hours per day with frequent walking. Frequent hand movement of 4-6 hours at one time 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 lifting and carrying of 15lbs. for 6-8 hours per day. Moderate lifting and carrying of 15-44lbs for 4-6 hours per day with a maximum lift of 45lbs. Occasionally bends and twists neck and waist. Occasionally reaches above and below shoulder height. Frequent foot movements. Hearing acuity essential. Color perception/discrimination, near and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. 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. Frequently performs routine tasks that vary little each day by following a set of written or oral instructions/procedures. Learn more about Grifols (************************************************* **Req ID:** 537221 **Type:** Regular Full-Time **Job Category:** MANUFACTURING

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Frist Shift **Quality Assistant/Associate Materials Evaluation Coordinator** **Summary:** The Quality Operations (QO) Assistant/Associate Materials Evaluation Coordinator evaluates critical quality attributes (visual, dimensional, functioncoordinates required chemical and/or biological testing, and executes approved usage decisions on all quality managed material used at the facility These evaluations are performed on a wide variety of materials including, but not limited to, chemicals, labeling components, primary drug containcomponents, process hoses, sterilizing filters, and other critical raw materials. This is done by verifying compliance to specifications and testingrequirements and ensuring required documentation is complete and accurate thus minimizing the possibility that the safety and efficacy of finalproducts manufactured and tested using these quality managed materials is compromised or adulterated. The Coordinators perform the last detailreview of these materials prior to release for use thus sound judgment is essential. The QO Assistant/Associate Materials Evaluation Coordinatorinspects product final container reserve samples according to approved standard operating procedures. The QO Assistant/Associate Materials Evaluation Coordinator may perform in the Packaging area as a Quality representative for sampling, auditing,making Qualitydecisions. In this area, the QO Assistant/Associate Materials Evaluation Coordinator audits final product batches using designatedsampling plans. Additionally, the Packaging QO Coordinator responsibilities include: reserve sampling, post-pack identity sampling, packagingcommodity verification and reconciliation, line clearance verification, and stability sample inspection. Decisions made by QO Coordinators have major compliance and monetary implications for Grifols. **Primary Responsibilities:** + Evaluate critical quality attributes (visual, dimensional, functional), coordinate required chemical and/or biological testing, and execute appusage decisions on all quality managed material used at the facility. + Issue and track Incidents/Raw Material Reports(RMRs) for discrepant material and quarantine product per approved procedures that governdisposition of such discrepant material. + Must stay abreast of the rapidly changing requirements of various regulatory agencies. New policy changes from these groups has a definitimmediate impact on Materials Evaluation responsibilities and release of material to production.Responsible for reconciliation of all product released (i.e.. Labels, plasma, raw material components, etc.) Non-reconciliation of material coumeans for material or plasma product recall and will impact product market availability. + Must possess extensive knowledge of cGMP, company specifications and distribution operating procedures.Associate QO Materials Evaluation Release Coordinators will serve as trainers to new employees in all aspects of this position and areconsidered to be a Subject Matter Expert (SME). **Knowledge, Skills & Abilities:** The incumbent must possess keen assessment skills and the ability to distinguish insignificant deviations from significant deviations that jeopardiintegrity of the material to be released. The incumbent must be able to learn and understand the concepts of statistical sampling used in daily activ Computer skills are required. Must be able to read and understand technical drawings. Effective communication skills, including proper grammar, essential in order to report (both in writing and verbally) data and product impact. Must keep neat, accurate, and complete records of materialevaluations and release activities performed. Tactful human relation's skills are essential to achieve cooperation between business partners andcustomers. Incumbent must have prior inspection experience (i.e. manufacturing components, packaged goods, etc.) **Education:** Requires minimum of an Associates degree with an emphasis in sciences or mathematics or an equivalent combination of education and experiencacceptable. **Experience:** A minimum of one year of related experience, preferably as a QC Assistant Materials Evaluation, is required for the QC Associate Materials Evaluation position. Incumbent must have prior inspection experience (i.e. manufacturing components, etc.). **Equivalency:** Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competenciemay be considered in place of the stated requirements. Example: If a job level typically requires an Associate's degree plus 2 years of experience, equivalent could include 4 years of experience or a Bachelor's degree. **Occupational Demands:** When working with raw material chemicals, the incumbent must be able to wear all required safety equipment such as protective eyewear, garmentsgloves and able to work with limited supervision. Must demonstrate initiative and have the ability to defend a decision based on specifications andprocedures. In addition the incumbent must have near vision correctable to at least 20/20 in one eye and 20/40 in the other eye, have no color blindexcellent color and depth discrimination, and be able to lift up to 50 lbs. The incumbent must be able to successfully pass the certification requiremfor product final container visual inspection. Work is performed in an office and a laboratory/manufacturing environment or warehouse. Exposure to biological fluids with potential exposure toinfectious 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 Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precisecoordinated 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. Colorperception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words andsentences. 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.** Learn more about Grifols (************************************** **Req ID:** 536840 **Type:** Regular Full-Time **Job Category:** TECHNICAL

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. **Responsibilities:** This role provides plant maintenance engineering support for 24x7 manufacturing operations at the Grifols Clayton site, Building 300 Purification. The Maintenance/Plant engineer has the primary responsibility for: + Ensure reliable production area operation in compliance with safety, regulatory, and production requirements while making independent decisions and resolving conflict within defined areas of responsibility. + Troubleshoot and identify root-cause mechanical system issues and process related problems so they can be corrected. + Become the mechanical, chemical, and process SME for the areas of responsibility within the building while serving as a consultant to management within that specified area. + Plans and organizes cross-functional activities. Partner with operations, maintenance and project engineering to identify and resolve issues (redesign, rebuild, repair, etc). + Actively pursue and manage process optimization technology, help improve operational efficiency, and implement continuous improvement projects. Advances technical project proposals through to completion. + Oversee outsourced vendor support. + Assist in training maintenance, instrumentation, and operations personnel. + Additional responsibilities include materials clearance, spare parts inventory, change controls, incident investigation, participating in safety reviews, specifications, leading projects during plant shutdowns and other common GMP engineering tasks. **Additional Skills Needed:** + Self-motivated and driven to succeed + Hands-on and a problem solver. Greater time in the field than at the desk. + Communicates effectively and promptly at all levels of the organization. + Strong theoretical and practical technical understanding with strong troubleshooting skills. + Works well with technical and non-technical personnel. + Solid technical writing and verbal communication skills. + Candidates with GMP and/or pharmaceutical industry experience are preferred **Requirements based on level:** **Engineer II:** + Bachelor's Degree in engineering or related field. + At least 2 years of experience. + Minimum of 2 years of experience working in a Biotech or Chemical company. GMP experience preferred **Engineer III:** + Bachelor's Degree in engineering or related field. Professional certifications and licenses as appropriate. + At least 4 years of experience. + Biotech, Chemical or Industrial experience preferred. **Engineer IV** + Bachelor's Degree in Engineering or related field. + Typically requires 5 years of related experience. + Biotech, Chemical or Industrial experience preferred. **Senior** **Engineer** + Bachelor's Degree in Engineering or related field. + Typically requires 6 years of related experience. + Biotech, Chemical or Industrial experience preferred. **Staff** **Engineer** + Bachelor's Degree in Engineering or related field. + Typically requires 7 years of related experience. + Biotech, Chemical or Industrial experience preferred. **Principal** **Engineer** + Bachelor's Degree in Engineering or related field. + Typically requires 8 years of related experience. + Biotech, Chemical or Industrial experience preferred. Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. 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; 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:** 534796 **Type:** Regular Full-Time **Job Category:** ENGINEERING / MAINTENANCE

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: The Director of Quality Operations ensures that all plasma donor centers in the United States consistently operate in full compliance with FDA and PPTA regulations, corporate quality standards, and industry best practices. The role provides strategic and operational leadership of Quality Operations across all centers, overseeing the deployment and continuous optimization of the Quality Management System (QMS), product quality, donor safety, and regulatory readiness while fostering a strong quality culture across the organization. Primary Responsibilities: * Leadership & Strategic Direction * Lead and develop a national Quality Operations team (Regional Quality Managers and center Quality personnel). * Establish strategic priorities for Quality Operations aligned with corporate goals. * Ensure effective communication, collaboration, and alignment with Operations, Medical Affairs, Regulatory, and Quality counterparts. * Compliance & Quality Oversight * Ensure donor centers comply with US FDA, EMA, PPTA IQPP standards, CLIA/COLA, and state regulations. * Maintain audit and inspection readiness across all centers. * Oversee investigations, deviations, CAPAs, complaints, donor safety events, and product quality issues. * Quality Management System (QMS) * Oversee implementation and effectiveness of QMS elements at Donor Center level: Change Control, Document Management, CAPA, Training, Risk Management, Supplier Quality. * Ensure procedures are implemented consistently and updated according to regulatory or corporate requirements. * Support harmonization of quality processes across all donor centers. * Product Quality & Operational Controls * Ensure plasma collection, processing, labeling, storage, and shipment meet GMP and IQPP standards. * Monitor product quality trends * Support product release, hold disposition, and quality decisions impacting customers. * Performance Monitoring & Reporting * Establish and track quality metrics, KPIs, dashboards, and trends for Donor Centers * Communicate performance and risk indicators for Donor Centers to senior leadership. * Lead continuous improvement initiatives and process optimization for Donor Centers. * Cross-Functional Collaboration * Partner with Operations, Engineering, IT, Medical, Supply Chain, and Regulatory Affairs to ensure integrated, compliant processes at Donor Center level. * Support equipment qualification, calibration programs, system validation, and operational readiness for new technologies. * Training, Coaching & Quality Culture * Ensure ongoing training and competency development for Quality staff at Donor Centers level. * Promote a proactive quality mindset with strong ownership at Donor center level. * Lead initiatives to strengthen quality behavior and compliance across donor centers. Additional Responsibilities: * Problem Solving * Solves complex operational and compliance issues requiring interpretation of regulations, trend analysis, and cross-functional inputs. * Apply risk-based decision making and scientific reasoning to determine corrective actions, process improvements, and quality controls. * Able to anticipate and prevent quality risks across multiple centers. * Decision-Making Authority * Approves quality decisions affecting donor safety, product quality, and regulatory compliance. * Together with Quality Assurance Director, makes determinations on deviations, investigations, holds, CAPAs, and procedural adherence. * Escalates significant issues to VP US Plasma Quality & Medical and Quality Assurance Director, as needed. * Helps define strategic quality priorities for the plasma collection network. Knowledge, Skills, and Abilities: * Deep knowledge of FDA/EMA/PPTA/WHO and applicable regulations or guidances. * Leadership and people development. * Proven success in driving cross-functional improvements. * Risk management and root-cause analysis. * Analytical and data-driven mindset. * Excellent communication, negotiation, and influencing skills. * Operational excellence and continuous improvement capability. Education and Experience: * Bachelor's in Life Sciences, Pharmacy, Biology, Nursing or related field (required). * Master's degree preferred. * Typically requires 10 years in GxP or plasma/biologics Quality roles. * 5+ years leading multi-site Quality Operations teams. * Strong inspection management experience (FDA, EMA, PPTA, CLIA/COLA, State, internal audits). * Experience with QMS systems (TrackWise, etc.). Occupational Demands: * Based at RTP headquarters, occasionally remote role with 40-60% travel to US plasma centers. * May require off-hour availability to respond to critical quality events, inspections, or escalations. * Fast-paced, multi-site operational environment. This position is eligible to participate in up to 30% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years - we're growing, and you can grow with us! #BiomatUSA #LI-RL1 #LI-HYBRID 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:USNC0001 - RTP NC-Headquarters

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. Phlebotomist - We Train You are a fit for us if you have: * Superior customer service standards * A High School diploma or GED * Ability to work a flexible schedule * An interest in making a difference in the world * Obtains required state licensures or certifications where applicable Phlebotomist Our ideal phlebotomist is patient, reliable, and really commits to keep our donors comfortable and happy. Primary Responsibilities: * Assist in determining the suitability of donors. * You establish rapport with donors to ensure overall customer happiness while ensuring donor confidentiality. * You respond to and assist with handling donor reactions. * Monitors donor and equipment to ensure health of donors and quality of product. * Sets up, disconnects, and operates the automated plasmapheresis machines. * Disconnects and disposes of all contaminated disposable equipment. We're Grifols, a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care. Occupational Demands Form # 74: Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while working in plasma freezer. Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear. Work is performed standing for 6 to 8 hours per day. Bending and twisting neck and waist for 1-2 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. Frequent foot movement; may infrequently squat, crouch or sit on one's heels. May walk up to 6-8 hours per day. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to comprehend and follow instructions to complete assigned tasks. must possess the ability to listen to and understand information and ideas presented through spoken words and sentences. must perform within the guidance of both oral or written instructions. Relates sensitive information to diverse groups. #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-Raleigh:USRA2 - Raleigh NC-Garner Sta Bl-TPR

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. **Primary Responsibilities for Role:** + Electrical and Instrumentation (E&I) Engineer for the pharmaceutical industry. + Will be required to manage assigned scope, cost, and schedule for responsible duties. + Will work in all phases of capital projects: planning, design, procurement, construction and start-up: + Design of low voltage power distribution and motor control. + Responsible for selection and sizing of instrumentation based on P&IDs. + Selects control system hardware based on site standards. + Prepares equipment specifications and bid packages. + Performs vendor & bid evaluations, progress monitoring and attendance of factory acceptance testing. + Responsible to field supervise contractors during construction to ensure safety, quality and schedule. + Responsible for providing contractors answers to questions that arise during construction. + Performs equipment start-up, develops and executes commissioning protocols and prepares turnover packages for the site. + Develops single lines, motor control schematics and loop sheets. + Sizes electrical components based on NFPA 70. + Modifies existing or develops new specifications to meet requirements of project scopes. + Coordinates with other disciplines throughout design, construction and startup. + Provides initial configuration settings for VFDs and Motor Starters. + Communication - Will be responsible for providing communications (verbal/written) within area of responsibility. + Use/demonstrate problem solving skills in order to best support and meet the needs within area of responsibility. + Promotes a collaborative and cooperative environment which embraces the ability to work effectively within teams. + Capable of adhering to Good Manufacturing Practices (GxP) - Compliance, Change Control, Quality Oversight, Validation. **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. + Will require occasional international travel (i.e. 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. \#LI-VJ1 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.** Learn more about Grifols (************************************** **Req ID:** 536220 **Type:** Regular Full-Time **Job Category:** ENGINEERING / MAINTENANCE

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 Grifols has been a leader in the healthcare industry since 1909 by creating innovative products and services based on the values of ethics, quality and responsibility. Grifols' activities focus on fulfilling the needs of its patients as well as healthcare professionals working in therapeutics, pharmacy, diagnostics and blood banking. For more than 100 years, Grifols has developed, manufactured and marketed products designed to improve human health. Grifols manufactures plasma derived biopharmaceutical products of proven efficacy, quality and safety. For more information, please visit our website:

**The Opportunity** Responsible for greeting donors at the plasma collection center and conducting a series of registration procedures to verify donor suitability for the plasma pheresis process. You will report to the Assistant Center Manager. **The Role** + In compliance with Standard Operating Procedures (SOPs), assists qualified donors in completing the screening process. The screening procedures includes but are not limited to: assessing the self-administered health history, answering basic medical questions associated with the donation process, referring donors to medical staff when appropriate and performing health screening procedures such as blood pressure, pulse, weight, temperature. Performs finger stick to obtain sample to obtain donor's hematocrit and total protein levels. + Upon completion of the appropriate training, may educate new donors on the use of therapeutic products made from donated plasma. This includes explaining the screening process, the health screening tests performed, the appointment system, donation fees, center policies, proper nutrition and any other information pertinent to the donor. Ensure that all donor questions are answered timely, accurately and professionally. + May be involved in registering applicant and transfer donors based upon completion of appropriate training and operational needs of the center. + May answer the telephone and answer callers question or transfer call to appropriate staff member. + Maintain alertness and awareness to any reaction by a donor may have during or after the pheresis process and notifies appropriate staff. + Alerts Group Leader or Supervisor of donor flow issues. + Ensure the accurate recording of donor data in the electronic donor information management system as outlined in the SOPs. + Understand the policies and procedures associated with hyper immune programs at the center if applicable.9 Maintains clean efficient work environment and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promote safety in all actions. + Maintain confidentiality of all personnel, donor and center information. + May be cross-trained in other areas to meet the needs of the business. + Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business. + Perform other job-related duties as assigned. **Your skills and experience** **Education** High school diploma or equivalent required **Experience** + Minimum of three (3) months experience in a clerical or customer service related position, preferably in medical or health provider environment or equivalent combination of education and experience + Will perform basic math calculations **Working Conditions** + Understand, remember and apply oral and/or written instructions + Understand and follow basic instructions and guidelines + Must be able to see and speak with customers and observe equipment operation. + Occasionally perform tasks while standing and walking up to 100% of time + Reach, bend, kneel and have high level of manual dexterity + Occasionally be required to lift and carry up to 25 pounds + Fast-paced environment with frequent interruptions + Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens + Required to wear Personal Protective Equipment while performing specific tasks or in certain areas + Required to work overtime and extended hours to support center operational needs **About CSL Plasma** CSL Plasma operates one of the world's largest and most sophisticated plasma collection networks, with over 350 plasma collection centers in the U.S., Europe and China. Headquartered in Boca Raton, Florida, CSL Plasma is a subsidiary of CSL Behring, a global biotherapeutics business and a member of CSL. Plasma collected at CSL Plasma facilities is used by CSL Behring for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people. Learn more about CSL Plasma here ************************** and CSL, CSL Behring, CSL Seqirus and CSL Vifor here ******************** . Learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor here at ******************** and CSL Plasma at ************************** . **Our Benefits** For more information on CSL Plasma benefits visit **************************** . **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 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 . R-265980 CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. ************************************************

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: 7am-7pm Day Shift** **Summary:** The Manufacturing Supervisor is responsible for a Manufacturing department's day to day operations to ensure the manufacture of products are within cGMP, safety regulations and policies and procedures. This is an entry level Supervisor role. Provides routine technical support and makes decisions within a well defined area of responsibility. **Primary Responsibilities for role (level specific responsibilities should be included in the chart below):** + Directs shift operations and ensures product integrity in accordance with the production schedule, cGMP, safety regulations and policies & procedures. + Maintains floor presence to minimize discrepancies and promote process compliance and accurate documentation. + Participates in process/product troubleshooting in order to correct/maintain desirable process parameter. + Acts as an initial point of contact for partner groups (i.e. Maintenance, Quality, Tech Doc Support, etc.) Research and address simple process deviations, documentation errors, etc. + Qualified to operate all equipment and lead processes to ensure the production schedule is met. + May recommend and with direction, implement measures to improve production methods, equipment performance, facility layout and quality of product. + Manage employees performance, coach and counsel for development. + Ensures required training for employee is achieved, effective and timely. + Makes decisions independently, but within a well-defined area. + Sought for counsel within field of expertise. 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/or supervisors may assign other duties as needed. **Knowledge, Skills and Abilities** + Ability to communicate effectively at all levels of the organization. + Ability to lead teams and promote a positive and thriving team environment. + Ability to troubleshoot and provide sound solutions for complex process related matters. **Education:** + BA/BS degree + 2 years related experience. + Masters degree + 0 years **Experience:** + Previous leadership 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. Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to extreme cold below 32*, miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on production floor. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 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. Often performs duties standing. Frequently bends and twists neck and waist. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Frequently drives to other facilities. 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. Frequently interacts with others, relates sensitive information to diverse groups. 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.** Learn more about Grifols (************************************** **Req ID:** 537176 **Type:** Regular Full-Time **Job Category:** MANUFACTURING

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. **This is an hourly, entry-mid level position with some office exp needed.** **Plasma Process Data Analyst I** **Summary:** The Plasma Process Data Analyst maintains and prepares plasma yield and accountability reports; performs data entry using various software (i.e. Bioman, SAP, etc.) programs. He/she also prepares graphs, retrieves and verifies production data (yields and inventories); identifies discrepant data, yield trends, problem yields and provides analysis of yield data. **Primary responsibilities for role:** ● Maintains and generates a variety of reports (i.e. yield, trending, efficiency or KPIs, etc.) ● Enters data into database using various software (i.e. Bioman, SAP, Excel, etc.) ● Prepares graphs, collects and verifies production data (i.e. yield, inventory, etc.) ● Identifies discrepant data, yield trends, etc. ● Reviews process orders in order to determine what components (i.e. stoppers, etc.) are needed to meet production schedule ● Maintains inventory of production supplies (i.e. gowning or lab coats, operating and cleaning supplies, etc.) ● Prepare annual product reviews. ● May review Batch Production Records (BPRs) and SOPs for accuracy. ● Interacts with external vendors in order to secure components/supplies needed for the department. ● Other duties as assigned (i.e. projects, etc.) **Additional Responsibilities:** Alert Manufacturing if changes are made which impact BPRs. **Knowledge, Skills, and Abilities:** Requires the ability to analyze production data at various stages; May be required to interpret yield data; Must be able to work independently with a high degree of accuracy; May be able to detect inconsistencies, deviations and trends, etc. **Education:** High School diploma or equivalent. An associate's degree is preferred. An equivalent combination of education and experience may be considered. **Experience:** A minimum of two years of relevant experiences is required. Incumbent must have good written and verbal communication skills; the ability to analyze, proofread, and edit data; and possess excellent computer skills. **Equivalency:** Depending on the area of assignment, directly related experience or a combination of directly related education and exprience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires an Associate's degree plus 2 years of experince , an equivalent could include 4 years of experience or a Bachelor's degree. **Plasma Process Data Analyst II** **Summary:** The Plasma Process Data Analyst II performs all duties of the Data Analyst I and performs a thorough forecast/analytic review of materials for the production and supplies needed in Manufacturing production to aid in financial audits, component inventory levels and on low/high yields that is utilized by Senior Management to make key decisions in these areas. **Primary responsibilities for role:** ● Perform all duties of a Plasma Processing Data Analyst I. ● Investigates and provides in-depth information to Sr. Management from financial reports on low/high yeilds. ● Analyzes inventory levels in SAP/quality incoming inspection and provides direction on priority of materials to be inspected /added to priority list. ● Provides memos to the investigation group to support incident investigations and to release quarantine material. ● Reconciles variances in SAP in order to be audit ready; department lead for finance audits. **Knowledge, Skills, and Abilities:** Requires the ability to analyze production data at various stages; May be required to interpret yield data; Must be able to work independently with a high degree of accuracy; May be able to detect inconsistencies, deviations and trends, etc. Strong SAP and/or excel experience. **Education:** High School diploma plus 4 years relevant experience. An associate's degree is preferred plus 2 years experience. **Equivalency:** Depending on the area of assignment, directly related experience or a combination of directly related education and exprience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires an Associate's degree plus 2 years of experince , an equivalent could include 4 years of experience or a Bachelor's degree. 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. Recruiter - Kaleena Rozier 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.** Learn more about Grifols (************************************** **Req ID:** 535651 **Type:** Regular Full-Time **Job Category:** MANUFACTURING

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. 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]]

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 a key member of the team, the incumbent will provide comprehensive technical and scientific expertise in the development, scale-up, transfer, and support of production processes for plasma-derived proteins. The role focuses on advanced purification unit operations, including but not limited to precipitation, filtration, chromatography, tangential flow filtration, formulation, nanofiltration, and process troubleshooting. The successful candidate will leverage their scientific knowledge and hands-on experience to contribute to the advancement of innovative therapies. Primary Responsibilities: Support developmental projects, clinical manufacturing, and commercial manufacturing. Assist in the development and execution of action plans to support departmental goals. Prepare procedures and technical reports independently, including data analysis and interpretation. Report technical results in internal and cross-functional team settings. Develop solutions to complex technical problems within the area of expertise. Design scientifically rigorous experiments, including the interpretation of results. Ability to execute experiments independently and in a team setting. Conduct laboratory and clinical production work using standard processing and analytical equipment. Identify and collect data on critical process attributes and/or critical parameters for scaling. Support the start-up and commissioning of equipment and processes and the implementation of new raw materials on-site. Maintain laboratory and clinical manufacturing facilities in accordance with procedures. Knowledge Skills and Abilities: Possess the ability to set and meet deadlines, multitask, and prioritize personal objectives based on project needs. Exhibit the ability to adapt to a changing work environment. Have experience in technical writing and effective oral communication skills. Apply scientific or engineering principles to problem-solving. Be adept at working at various process scales, ranging from bench to pilot scale. Have knowledge and experience working in a GMP environment. Takes initiative to stay current in area of specialization (e.g., chromatography, filtration) and expand knowledge base. Be self-motivated and able to work effectively in a matrixed organization. Be proficient in using the MS Office Suite. Location: Clayton, NC Shift: Day Education and Experience: Senior Associate Process Development Engineer I Level: Bachelor's degree in a relevant science or engineering field with 4+ years of relevant work experience, Associate's degree with 6+ years of experience, or an equivalent combination of education and experience. Occupational Demands for Engineer: Work is performed in a clinical and/or 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. 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. 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. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently works with diverse groups to obtain consensus on complex issues. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. 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

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

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. **Plasma Classification Certified Inspector** **1st Shift - Monday - Friday 5:00am - 1:30pm** Position requires scanning and removal of unsuitable plasma units utilizing the Plasma Management System (SGP). A visual inspection of plasma units is also performed, removing any units which are unacceptable (e.g. damaged, broken port/tube, RBC, or backup sample rejections). Employee must be able to perform secondary verifications and Perform end of PU line clearances. **Responsibilities** + Scanning of plasma units assigned to a PU utilizing a barcode reader. + Scanning of archive samples assigned to a SA utilizing a barcode reader. + Transferring units to a Sub-shipment during the PU process. + Entering "Statistics" during the PU process. + Sub-shipment verification at the end of the PU process. + "Blocking" of units which do not meet customer requirements. + Responsible for various rejections found during visual inspection. + Removal of unsuitable plasma units marked for removal in SGP during the PU process. + Able to maintain record accountability. + Able to perform job duties with minimum supervision. + Ability to follow written procedures. + Monitoring plasma time out of freezer + Department housekeeping and safety practices + Processing of unsuitable plasma units during any step of the plasma process. + Transfer of unsuitable plasma units (status 100) to correct reject inventory + Transferring units between PU/LOT to a PU. + Ability to consistently meet department average throughput. + Knowledge of SGP Status codes and Disposition Codes. + Knowledge of labeling Requirements. + Scanning of case/units to a 3rd party sale utilizing Disposition Module. + Scanning of case/units to a MDO process utilizing Disposition Module. + Completing the partial PU cases between PU's. + Line Clearance at the end of a Plasma Process. **Requirements** + High School diploma or equivalent. + Two years' experience in Manufacturing, Pharmaceutical or other FDA licensed Industry is desirable. + Knowledge of cGMPs and Industry Standards. + Ability to follow "Standard Operating Procedures". + Possess good verbal and written communication skills. + Possess basic math skills (addition, subtraction, division, multiplication). + Basic Computer skills. **Occupational Demands** Work is performed in a manufacturing environment with rotating shifts. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to chemicals, electrical manufacturing equipment, hand tools and moving machinery. Exposure to high levels of noise and to extreme cold below 32*. Occasional entry into confined spaces requiring kneeling and squatting. Operates forklifts, tractors and power equipment. Personal protective equipment required such as protective eyewear, safety shoes, gloves and garments. Work is performed standing and walking for 6-8 hours per day. Bending and twisting neck and waist 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. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement. Frequent moderate lifting and carrying of 15-44lbs. Frequent heavy lifting and carrying of 45lbs. with a maximum lift of 50lbs. Occasionally reaches above and below shoulder height. Hearing acuity essential. Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. 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. Frequently performs simple and routine tasks that vary little each day by following a set of written or oral instructions/procedures. **We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years - we're growing, and you can grow with us!** \#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-Clayton:USNC0002 - Clayton** Learn more about Grifols (************************************** **Req ID:** 537774 **Type:** Regular Full-Time **Job Category:** MANUFACTURING

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Summary: Leads the R&D Regulatory Strategy group for assigned products in managing regulatory programs in support of R&D activities. Oversees and/or participates in the development and implementation of worldwide regulatory programs for new product or new indication development, and leads interactions with regulatory authorities to expedite approvals. Coordinates department activities with related RA functions to assure efficient and consistent execution of department functions. Represents the department at senior-level, cross functional teams, applying advanced knowledge of regulations and interpretation of technical guidelines to assure execution of regulatory strategies and adherence to regulatory requirements. Oversees staff to ensure the efficient operations of the function. Primary Responsibilities: * As Global Regulatory Lead, develops and oversees worldwide regulatory strategies for projects and issues affecting new products or new indication development. * Leads interactions and negotiates with global regulatory authorities regarding programs and initiatives that significantly impact the business. * Serves as a resource to other departments inside and outside of R&D on regulatory-related product development issues. * Guides, directs, and leads staff, and develops department goals in accordance with business priorities. Responsible for training, reviews and development of department members. * Advises Senior Management on regulatory aspects of product development and/or lifecycle management. Identifies business implications of complex regulatory and clinical issues, develops risk mitigation strategies and communicates in a manner that facilitates decision making. * Serves as Grifols regulatory liaison in collaborative projects with other companies * Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements. * Manages department resources and budget to meet R&D goals * Utilizes scientific training when interfacing with Senior Management of technical areas to guide the scope of experimentation and the selection of data needed to support regulatory submissions Knowledge, Skills, & Abilities: Comprehensive knowledge and understanding of FDA and global regulatory requirements for the biotechnology and pharmaceutical industry. Deep experience in clinical development, trial design statistical principles is essential. Excellent oral and written communication skills. Strong critical thinking and problem solving skills. Excellent and demonstrated project management skills. Ability to negotiate and influence regulatory officials. Ability to work cross-functionally to effectively implement and oversee R&D regulatory programs. Ability to evaluate complex issues, develop a plan, and meet deadlines to ensure compliance, as well as business timelines to accomplish company objectives. Ability to work within a global team framework and multi-cultural environment. Minimum Requirements: Requires Ph.D., Pharm. D.,M.D. or equivalent and, 8 years direct experience in Medical Research, Clinical, Regulatory Affairs or other critical areas within the pharmaceutical industry. 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. Frequently walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations and frequently travels within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. 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 || NORTH AMERICA : USA : NC-RTP:USNC0001 - RTP NC-Headquarters