Grifols jobs in Fayetteville, NC

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Position Overview: Provides HR administrative support with the day to day operations in one or more of the following HR functions: Benefits, Business Partners, Communications, Compensation, Corporate Health, Employee Relations, Environmental Safety and Security, HRIS, Professional Development/Organizational Development, Staffing and/or Training-TPR. Job responsibilities include but are not limited to the following: ● Provides excellent customer service to divisional HR staff and employees. ● Prepares and maintains reports that are necessary to carry out the functions of the HR department. ● Organizes and maintains employee files. ● Enters and audits HR transactional data into a centralized HR database and ancillary HR systems. Ensures the information is accurate and adheres to corporate standards. ● Processes various forms related to documenting HR activities such as new-hire, change-of-status, performance evaluations, benefits, terminations, dependent eligibility audit, etc. ● Processes diverse and confidential information requiring extreme accuracy, independent judgment and discretion. ● Responds to questions from internal and external customers. ● Multi-tasks on a daily basis and prioritizes work. ● Schedules appointments, meetings, and interviews. Makes arrangements for travel. ● Performs data gathering and analysis. Performs basic recruiting activities including interviewing non-exempt positions. Skills/Qualifications/Education Requirements: (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions). * Associate's degree preferably in HR * Typically requires 4 years of HR experience * Excellent knowledge of HR policies, programs, operations and benefits * Excellent skills in Microsoft Office, Excel, and Word * Excellent verbal and written communication skills * Ability to multi-task in a fast-paced environment * Ability to communicate clearly and concisely over the telephone and to deal with difficult situations * Ability to manage multiple projects by prioritizing tasks and escalate issues in need of resolution * Ability to analyze and interpret data, identify errors and formulate solutions * Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires an Associate's degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor's degree. Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequently walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 30lbs. 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 words and sentences. Interacts with others, relates sensitive information to diverse groups. #LI-CB1 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

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About BioLife Plasma Services Every day 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. OBJECTIVES/PURPOSE Monitors designated systems and activities, according to tasks trained and assigned, to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center. Is able to perform all technical tasks required within the work areas and will work in these areas as a Lead Technician (or Center Supervisor by exception) when not acting as the Quality Lead Technician. All below listed responsibilities must be completed in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to the proper performance of day-to-day activities. Employees must also maintain complete and accurate records, in accordance with cGMP. ACCOUNTABILITIES Performs duties associated with Quality (including but not limited to): (50%) Reviews operational records in association with tasks trained and assigned to ensure they are complete, accurate and compliant with cGMP requirements. Tracks deviations in operating procedures and policies through established mechanisms. Reports error, deficiencies, discrepancies and observations to center management and Quality Management Representative (QMR). Conducts monthly quality assurance audits for critical control points and key elements for the systems related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, and employee training program. Ensures SOP's are current and that staff perform routine tasks according to SOP through direct observation. In the absence of a QMR, works in collaboration with the management team to prepare for and host (if needed) internal auditors and external inspectors. Assists center management teams to ensure timely closure of observations. Maintain qualifications and perform all duties (core and elective) for Medical History, Phlebotomy, and Sample Processing areas. Train new and existing staff on donor center procedures through demonstration, instruction, observation, and feedback. (30%) Provide leadership and training assistance in support of center management and supervisory team, including oversight of operational flow. (10%) Maintain certification and perform all required duties of Lead Technician. (10%) DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise A minimum of one year of relevant work experience, preferably in a regulated industry, or an equivalent combination of education and experience. Certification in all three primary operational areas of the plasma center (Medical Historian, Phlebotomy, and Processing Technician). Completion of all training through Lead Technician. Demonstrated understanding of quality assurance in an FDA-regulated environment. Effective communication, organizational, and technical/problem-solving skills. Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream Mapping and Kaizen). Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment. Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records. Leadership Integrity Fairness Honesty Perseverance Putting the patient at the center Building trust with society Reinforcing our reputation Developing the business Decision-making and Autonomy Refers to Center Manager for guidance on complex, medium-impact or above decisions (internal) Refers to management team for escalated donor/employee concerns (internal) Interaction Responsible for providing exceptional customer service to donors (external) and fellow employees (internal) Attend staff meetings and other team meetings as required. Good verbal communication and customer service skills. Ability to multi-task and work as a team player. Innovation Coordinates will all other center roles to effectively problem solve, ensure safety of staff and donors, and provide an exceptional customer experience. Complexity Production environment requiring the ability to walk and stand for the entire work shift. Requires frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee. Requires frequent lifting up to 26 lbs. and occasional lifting of materials 32 lbs. - 50 lbs. Must have fine motor coordination, depth perception, and ability to hear equipment sounds from a distance. Due to potential exposure to blood borne pathogens (risk level 1), 90% of work tasks require pro-longed glove wear EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Essential: High School Diploma or equivalent required Desired: Associate or Bachelor's degree preferred ADDITIONAL INFORMATION FLSA Classification (US) - Non-Exempt Other duties and responsibilities as assigned. 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 - Fayetteville - Morgan U.S. Hourly Wage Range: $20.00 - $27.50 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsUSA - NC - Fayetteville - MorganWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt No

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

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

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 ; 6:00 PM- 6:00 AM ; rotating shift; (Training will take place on 1st shift the first 1 month) Week 1: M, T, F, Sat. Week 2: Su., W, Th. **Location:** Clayton This position is responsible for performing environmental monitoring on classified areas and utility systems. Depending on area of assignment, responsibilities will include the collecting and/or testing of environmental, utility, raw material, or validation samples utilizing test methods that are specific to the assigned laboratory. Candidates must be able to follow the requirements of Grifols, Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP) and complete work in a safe, accurate, and efficient manner. Responsibilities will also include performing non-routine duties, housekeeping duties, etc. as well as participating in projects such as standard and control preparations, method validations, comparison studies, etc. **Requirements** The Assistant level requires an AA or BS degree in medical technology/clinical laboratory science, or a BS degree in biology, chemistry, or related field in addition to 6-12 months of applicable laboratory experience. A background in medical technology / clinical laboratory science is preferred, as is experience in a GLP / GMP laboratory The Associate level requires an AA or BS degree in medical technology/clinical laboratory science, or a BS degree in biology, chemistry or related field in addition to 2 years of applicable laboratory experience. A background in medical technology / clinical laboratory science is preferred, as is experience in a GLP / GMP laboratory. Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures 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:** 536768 **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. The Jr. Production Planner is responsible for scheduling daily WIP inventories to enable annual sales of greater than $2 billion in a highly regulated environment. Material selection, scheduling, and assigned quality testing must meet the regulatory and quality requirements of the intended markets while maximizing throughput. The Production Planner must possess process knowledge of manufacturing interdependencies, constraints, and requirements to efficiently schedule their assigned area and react quickly to situations where contingency plans are required. The Production Planner drives plasma production in their assigned area and therefore must be able to communicate company goals/requirements to their customers. Primary responsibilities for role: * Create weekly production schedules within the capacity constraints [product, equipment or labor] as identified for each work center. Schedule effectively, maximize throughput and meet product outdate objectives for assigned production area. * Create weekly production schedules that align with capacities in upstream and downstream depatments. * Coordinates production to utilize equipment and manpower to meet production throughput targets and the release plan while balancing targets for interfacing schedules such as project, validation, and maintenance work. * Monitors pace of production ensuring timelines are met. Communicate status to Management. * Issues batch numbers, product codes, product inspection lots (including additional testing, if required for a specific customer), environmental monitoring inspection lots and serialization information based on source plasma specification and the regulatory requirements of the intended market. * Controls WIP with daily value in excess of $500M in support of greater than $2 billion in sales. * Correctly combines intermediate materials from multiple sources and specifications. * Monitors all WIP inventory. Tracks inventory to avoid write-offs due to expiration. * Manages proper inventory levels established for each WIP stage to avoid shortages and excesses. * Selects WIP to maximize throughput for stages with excess inventory. Ensures timely identification and destruction of excess WIP inventory. * Utilizes SAP for Production Planning, Inspection Lot Assignment, and Inventory Management transactions and generation of weekly schedules. * Utilizes OSM for generation of serialization information based on scheduled production orders and quality criteria as applicable for assigned production area. * Correctly assigns inspection plans based on market destinations and non-routine activities. * Provides support for 24/7 manufacturing operations. Additional Responsibilities: Regularly interacts with Manufacturing Managers, Sr. Supervisors, QA Product Line Managers, Supply Planners, Procurement staff and Director of Global Contracts. Knowledge, Skills, and Abilities: * Knowledge of manufacturing processes and interdependencies, Supply Chain concepts and cGMPs. * Knowledge of SAP ERP system, Microsoft Office, Excel and database management. * Must be comfortable in a constantly changing environment and able to shift plans and priorities daily to meet mid and long-term objectives. * Excellent communication, organization, logistical and multi-tasking skills. Education: Minimum BS/BA degree in a relevant field required (Industrial Engineering, Supply Chain, Operations Research, Pharmacy, Biology) Experience: * One year of applicable work experience in materials and or manufacturing scheduling; Biological or Pharmaceutical environment desirable (i.e. Co-op experience). * Proficiency in Excel and or database management systems required. Equivalency: The Jr. Production Planner requires a BS/BA degree in a relevant field (Industrial Engineering, Supply Chain, Operations Research, Pharmacy, Biology). 1 year of applicable work experience in materials and or manufacturing scheduling is desirable. Equivalent experience via Co-op, internship may be considered. Occupational Demands: Work is performed in an office environment with exposure to electrical office equipment. May occasionally enter BioRisk Area. Exposure to biological fluids with potential exposure to infectious organisms. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated 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-Clayton:USNC0002 - Clayton

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. Location: Clayton NC Inventory Analysts work within a regulated environment to manage inventory levels for both direct and indirect materials necessary for the manufacture of biological products. They monitor current usage, project future usage based on existing production plans, determine replenishment requirements and place purchase requisitions to ensure no interruption to the manufacturing plan while ensuring attainment to inventory objectives. This position will collaborate cross-functionally with Procurement, Quality, Operations and Regulatory Affairs. The Inventory Analyst II may be assigned to projects or serve as a representative of the department at meetings. Primary responsibilities for role (level-specific responsibilities should be included in the chart below): ● Analyze MRP, manage inventory levels, determines safety stock levels and implements inventory policy changes, executes purchase requisitions. ● Identify and analyze risk initiatives for production raw materials and indirect materials. Develops scenarios and material mitigation strategies to minimize material shortage. ● Monitors and proposes changes to production schedules (consensus), monitor QO release of materials. Identifies downstream impact of production schedule changes. ● Track, make recommendations and implement cost savings strategies ● Manages raw materials for new project initiatives. May participate in 3-5 project initiatives and lead at least 1 project initiative. ● Proactively manages inventory risk during change management process and identifies operational impact. ● Develops and improving methods for performing risk assessment. ● Review, analyze and generate purchasing requisitions. Develops scenario analysis as needed and make recommendations in alignment with inventory policies. ● Adhere with company policies and procedures. ● Supervise or coordinate work assignments for other Inventory Analysts. Additional Responsibilities: Interacts daily with all levels of employees to include Supervisors, Managers, Directors, Proceurement, Regulatory and GT Planning, Quality and Finance to resolve inventory issues and ensure inventory targets and other key business objectives are achieved. Inventory Analyst II may lead cross-functional teams and participate on cross-company teams. Knowledge, Skills, and Abilities: Must operate in a highly regulated (cGMP) environment and have a strong understanding of market quality and regulatory requirements. Interact daily with all levels of employees to include Supervisors, Managers, Directors, Purchasing, Regulatory, Global Supply Planning, Quality Operations and Finance to ensure inventory issues are resolved and inventory objectives are achieved. Strong negotiation skills with the ability to influence others to achieve the company's vision. May participate on cross-company teams. Education and Experience Requirements: Inventory Analyst I: Education: Bachelor's Degree in Business, Supply Chain, Operations or related field required or equivalent of Associate degree with 5 years of experience. Advanced degree preferred. Experience: * At least three (3) years work experience required in Production/Supply Planning/Inventory management preferably in a Biological or Pharmaceutical Environment. * Excellent oral and written communication skills. * Agile and able to manage complex and dynamic variables. * Must have excellent analytical and strategic thinking skills and the ability to develop alternate strategies and influence others. * Ability to develop customer relationships through collaboration, respect, professionalism, trust, and integrity. * Knowledge of Production and supply planning processes, manufacturing constraints, regulatory requirements and cGMPs. * Proficiency in SAP ERP system and Microsoft Office is a non negotiable requirement for this position. Inventory Analyst II: Education: Bachelor's Degree in Business, Supply Chain, Operations or related field required or equivalent of Associate degree with 7 years of experience. Advanced degree preferred. Experience: * At least six (6) years work experience required in Production/Supply Planning/Inventory management preferably in a Biological or Pharmaceutical Environment. * Excellent oral and written communication skills. * Agile and able to manage complex and dynamic variables. * Must have excellent analytical and strategic thinking skills and the ability to develop alternate strategies and influence others. * Ability to develop customer relationships through collaboration, respect, professionalism, trust, and integrity. * Knowledge of Production and supply planning processes, manufacturing constraints, regulatory requirements and cGMPs. * Proficiency in SAP ERP system and Microsoft Office is a non negotiable requirement for this position. * Strong decision making skills. Occupational Demands: Work is performed in an office environment with exposure to electrical office equipment. May occasionally enter BioRisk Area. Exposure to biological fluids with potential exposure to infectious organisms. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated 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 and infrequent international travel. 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-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. **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. **Schedule : Monday to Friday 8:00 am to 5:00 pm** **Summary:** The Clayton Grifols Quality Compliance department provides leadership to support cGMP compliance of the large and dynamic multi-facility Clayton North Carolina campus. The North Carolina campus performs fractionation of blood plasma, purification, aseptic filling, lyophilization, final packaging, and warehousing of plasma related products. The Principle Quality Compliance Associate will support hosting external audits and will support and lead quality compliance and site initiatives for process improvement. The incumbent is a professional with high technical competency who leads project or discipline teams. The employee influences the direction of complex projects and communicates with all levels of personnel. The incumbent is recognized as an authority in multiple areas and provides leadership and guidance to others. The employee is a fully qualified professional who requires minimal supervision. Interactions by this position include collaboration within the GT Clayton site, other Grifols BioPharma sites, suppliers/customers, and/or regulatory agencies. As appropriate, this employee may serve as delegate to the department manager. Depending on background and the level of experience, this position may also be filled as a Sr. Quality Associate I or II. **Primary Responsibilities for this Role:** + Use expertise to advise and influence the technical decisions of business units + Demonstrates the ability to influence the decision makers in other departments + Has excellent communication skills (written and verbal) with demonstrated use of domestic (i.e. Food and Drug Administration CFR) and applicable foreign regulatory agency requirements/guidelines + Interacts regularly with members of management and as needed with regulatory officials + Leads multi-disciplined project teams with highly technical objectives. Communicates project proposals to senior management and follows project through to successful completion + May serve as manager delegate with demonstrated experience in Quality Systems and with GT products/processes + Prepares, organizes, and tracks documentation and requests in support of regulatory and customer audits + Authors, reviews, and revises responses to regulatory and customer audits + Coordinates and manages logistics of on site and remote regulatory and customer audits + Track and follow-up on audit commitments and corrective actions + Perform effectiveness checks for audit related corrective actions + Author Quality Agreements for Grifols Suppliers and Customers + Author Biological Product Deviation Reports + Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply **Additional Responsibilities:** + Prepares, reviews, and in some cases approves SOP revisions, Change Control Requests, Risk Assessments, Incident Tracking System entries and investigation reports + Revise / update and coordinate executive management review of the Grifols Clayton site master file + Manages and provides audit history information to internal customers + Compiles department metrics + Tracks corrective action resolution for near hit observations identified by management during regulatory or customer audits + Partners with stakeholders to identify and implement continuous improvement solutions with demonstrated / measured business results + Provides support to other functions within the Quality Compliance group + Provides guidance and training for other employees **Knowledge, Skills, and Abilities:** + Knowledge of domestic and foreign regulatory authority requirements + Investigation skills with nonconformances including root cause analysis and corrective/preventive actions + Excellent organizational skills and the ability to follow up on matters consistently and diligently until timely resolution is achieved + Demonstrated ability to consistently apply technical knowledge in making sound quality decisions with minimal guidance + Technical report writing skills with the ability to produce high quality documentation appropriate for the intended audience + Ability to think critically/strategically and act proactively + Demonstrates integrity and company values + Follows cGMP and departmental safety practices + Knowledge and experience using Microsoft Office applications **Other Preferences:** + SAP Quality Module + Strong Excel skills, familiarity with pivot tables This job description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Manager may assign other duties as needed. **Required Education:** **Sr. Quality Associate I, Quality Compliance:** BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 5 years relevant experience, or equivalent combination of education and experience. **Sr. Quality Associate II, Quality Compliance:** BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 6 years relevant experience, or equivalent combination of education and experience. **Principal Quality Associate, Quality Compliance** : BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 8 years relevant experience. A minimum of a BA/BS degree is required. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race, color, 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:** 536824 **Type:** Regular Full-Time **Job Category:** GENERAL SERVICES

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice (************************************** and Terms of Use (********************************************* . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers. About BioLife Plasma Services Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a Medical Support Specialist (Plasma Center Nurse) to support plasma center operations. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. About the role: Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will determine donor eligibility to donate plasma, management of donor adverse events, review of laboratory test results, and donor notification of unsuitable test results. The Medical Support Specialist (Plasma Center Nurse) works under the guidance of the Center Manager (or Assistant Manager as applicable) for operational guidance and under the management of the Center Physician for medical issues. The Medical Support Specialist will be familiar with regulations of the plasma collection industry or a manufacturing environment. The Medical Support Specialist follows guidance provided by BioLife Medical Affairs and provides center level support of environmental, health and safety (EHS). How you will contribute You will determine donor eligibility; to include, proper management of informed consent, AIDS education and confidential self-exclusion, medical history interview and acceptance requirements, physical examination, blood testing, and reviewing Serological Protein Electrophoresis (SPE). You will evaluate donor reaction(s), which occurs at the facility as outlined in the SOPs. Follow applicable SOPs for medical emergencies including the development of Center Physician's standing orders and donor transport to emergency care facilities. You will refer to the Center Physician or Medical Affairs (as applicable) when in need of providing unacceptable findings to donors, or guidance concerning medical or technical issues, including donor safety and eligibility. You will support the Hepatitis B and Seasonal Flu vaccination programs for employees as applicable. You will manage employee incidents and determine whether further evaluation is required by occupational health/ER. Refer to EHS guidance regarding employee incidents. You can be a Pandemic Coordinator when authorized by EHS and support investigations associated with pandemic threats within the local community as indicated by EHS or Medical Affairs. What you bring to Takeda: High school diploma or equivalent to including graduate equivalent of a recognized educational nursing program with state requirements Currently licensed or certified in the state where responsibilities will be assigned: Registered Nurse (RN), Nurse Practitioner (NP) or Physician Assistant (PA) Current Cardiopulmonary Resuscitation (CPR) and AED certification Fulfill state requirements (in state of licensure) for basic IV therapy Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist Two years in a clinical or hospital setting What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include medical/dental, paid time off and retirement benefits, all in a fast-paced, friendly environment. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to bring Better Health and a Brighter Future to people around the world. **BioLife Compensation and 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 - Fayetteville - Morgan **U.S. Hourly Wage Range:** $31.92 - $43.89 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. **EEO Statement** _Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._ **Locations** USA - NC - Fayetteville - Morgan **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time **Job Exempt** No

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

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 the option to 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: ****************************** OR ********************** **Purpose & Responsibilities of Position:** The objective of this role is to support the Business Development department in identifying innovative initiatives that contribute to the growth and continuous improvement of the Plasma Procurement business unit. We are looking for an Innovation Trainee with a curious mindset, proactive attitude, and eagerness to learn, to join our team and support the development of strategic initiatives and business transformation processes. **Key Responsibilities:** + Participate in the research phase to seek new ideas, initiatives, and/or technologies. + Conduct research to find new partnerships and collaborations. + Investigate emerging trends and new technologies applicable to the business. + Collaborate with multidisciplinary teams to develop innovative solutions and gather insights. + Contribute fresh ideas to the strategic challenges of the area. + Support the preparation of presentations and project progress reports. + Research new collaborations with universities or other institutions for courses, trainings, or educational sessions. **Eligible applicants include:** + Undergraduate students entering their junior or senior year, pursuing a degree in Business, Process Improvement (Innovation), Engineering or related areas.(Sophomore entering Junior year OR Junior entering Senior year) **OR** + College Senior going to Grad School (graduate students entering their first or second year of study) **Desired Skills:** + Interest in innovation, technology, and continuous improvement. + Analytical and problem-solving skills. + Knowledge in Design Thinking, Lean Start-up, AI, Project Management, or Business Development is valued. + Creativity and critical thinking. + Strong organizational, communication, and interpersonal skills. + Interest in customer/donor experience and healthcare services. + Ability to work independently and collaboratively in a fast-paced environment. + Proficiency in Microsoft Office (Excel, PowerPoint, Word). + A proactive attitude and willingness to learn. \#biomatusa Learn more about Grifols (**********************/es/web/international/home) **Req ID:** 535699 **Type:** Internship **Job Category:** GENERAL SERVICES

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. Location: NORTH AMERICA : USA : NC-Clayton:[[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. **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. 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.** Learn more about Grifols (************************************** **Req ID:** 536724 **Type:** Regular Full-Time **Job Category:** R & D

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. PRM Specialist 1: * Assist in the coordination of the filing, storage, archival, retrieval, and retention of controlled documents and records at the Clayton site. * Assist in maintaining Central Records Storage (CRS) system database and utilize to fulfill requests and catalog document submissions and attend all meetings * Must interact with the various departments at the Clayton facility and assist in the coordination, storage, retrieval and transfer of documents on a daily basis. * Support urgent requests (i.e. regulatory inspection/customer audit requests, information needed for batch release/certification, discrepancy investigation data, etc.). * Assist in ensuring all documentation is archived systematically in accordance with established procedures and document all monthly and yearly metrics. * Collaborate with other PRM specialists to ensure consistency and effective resolutions. * Follow established procedures to process requests from the Clayton site through the PRM retrieval process and maintain the integrity of the Physical Records * Assist in performing audit of archived records in accordance with established procedures to ensure document accountability. This is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. * Must be able to work independently with minimal supervision and accuracy and manage multiple deadlines. * Attention to detail and sense of urgency is required. PRM Specialist 2: * Coordinate daily activities associated with the maintenance and support of the Central Records Storage (CRS) area and conduct all necessary training of site-wide end. * Coordinate the filing, storage, archival, retrieval, and retention of controlled documents and records at the Clayton site. * Maintain CRS system database and utilize to fulfill requests and catalog document submissions and attend all meetings pertaining to CRS area. * Ensure all documentation is archived systematically in accordance with established procedures and document all monthly and yearly metrics. * Create and edit physical objects and mark physical objects for destruction. * Create new addresses and new containers for the warehouse. * Offer continuous improvement suggestions for efficient storage and retrieval processing. * Perform audit of archived records in accordance with established procedures to ensure document accountability and traceability. * Must be able to identify discrepancies or conflicts in storage and retrieval system that might impact the ability to retrieve packets and follow up with appropriate * Must be able to work independently with minimal supervision, accuracy, and manage multiple deadlines. * Attention to detail and sense of urgency is required. * Must be able to perform all responsibilities described in the PRM Specialist I . * Coordinate back up support as needed. * Support urgent requests (i.e. regulatory inspection/customer audit requests, information needed for batch release/certification, discrepancy investigation data, etc.). * Troubleshoot the validated PRM system as issues arise and offer solutions to problems. PRM Specialist Sr.: * Plan, organize, and coordinate daily activities associated with the maintenance and support of the Central Records Storage (CRS) area and conduct all necessary training. * Coordinate the filing, storage, archival, retrieval, and retention of controlled documents and records at the Clayton site. * Maintain CRS system database and utilize to fulfill requests and catalog document submissions and attend all meetings pertaining to CRS area. * Ensure all documentation is archived systematically in accordance with established procedures and document all monthly and yearly metrics. * Perform audit of archived records in accordance with established procedures to ensure document accountability, traceability and / or other pre-established criteria are met. * Act as business administrator to create folders and assign users to a group. * Create new containers for the warehouse. * Offer continuous improvement suggestions for efficient storage and retrieval processing. * Must be able to identify discrepancies or conflicts in storage and retrieval system that might impact the ability to retrieve packets and follow up with appropriate personnel * Must be able to work independently with minimal supervision, accuracy, and manage multiple deadlines. * Attention to detail and sense of urgency is required. * Support urgent requests (i.e. regulatory inspection/customer audit requests, information needed for batch release/certification, discrepancy investigation data, etc.). * Consults with management and offers solutions to inefficiencies/problems and makes continuous improvement suggestions. * Troubleshoot PRM system errors and coordinate fixes with IT and/or end users. * Must be able to perform all responsibilities described in the PRM Specialist I and II job descriptions. 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. **Summary:** The Regulatory Affairs Surveillance Specialist will determine and execute actions necessary BLA Licenses supplements and other regulatory submissions to ensure that Grifols Plasma Operations is in compliance with organizations similar to or including the US Food and Drug Administration (FDA), Clinical Laboratory Improvement Amendments (CLIA), Plasma Protein Therapeutics Association (PPTA), Commission on Laboratory Accreditation (COLA), Health Canada, and state/province and Rest of World (ROW) and other regulatory requirements, and that to meet business objectives are met. This may include licensing activities associated with plasma collection facilities, warehouse, laboratory, medical devices and any related projects for acquisitions, new product development, additions, closures or relocations, etc. May serve as a reviewer for federal submissions and may compile documents for final submission. **Primary Responsibilities:** + Compile and process regulatory submissions through coordination with other departments and research of internal documentation including: completing applications and forms; composing cover letters and summaries; assembling, formatting and packaging submissions in a manner to facilitate the review process; submitting and tracking submissions and providing updates on status; filing, archiving and distributing submissions electronically and in hardcopy. + Research Internal document, complete applications and forms, prepare cover letters and summaries; assemble and format applications in a manner to facilitate the review process. + Perform regulatory surveillance related to licensing activities, Source Plasma collection and medical device regulations. + Maintain up-to-date knowledge of regulatory requirements and changes in the regulatory landscape. + Communicate with U.S. and international agencies regarding regulatory requirements, obtain clarification and discuss and determine strategies for regulatory reporting. Filing as needed or required based upon projects/initiatives. + Identify and analyze compliance issues that impact regulatory compliance with the ability to propose solutions or escalate to upper management. + Review, monitor and coordinate regulatory meetings to review surveillance findings related to licensing activities, Source Plasma collection and medical devices regulations that has direct impact to the business. + Ensure management is aware on the status of submissions/applications. + Provide regulatory assessment on change controls for proposed changes. + Develop internal procedures and tools and conducts informational or training sessions for stakeholders. + May prepare and submit regulatory licensing applications to federal (U.S., Canada and ROW), state/province, local, and other regulatory authorities, as well as industry affiliates, through coordination with other departments. + Assist in preparing responses to regulatory agency inquiries + Record and maintain details of all interactions with all agencies through contact reports. + Educate and inform internal customers which may include corporate office and plasmapheresis centers regarding regulatory requirements using current regulatory citations, facts and figures to support positions. + Proofread, review and compile documents for Authorized Official signature for final submission to federal regulatory agencies. + Participate in company projects, may serve as department representative. + Responsible for ad hoc regulatory reporting (i.e. vaccine adverse events). + Maintain applicable shared mailboxes, dashboards and accounts related to licensing activities. + Perform other duties as required **Additional Responsibilities:** + Represent department on cross-functional project teams, as required. + Serve as team lead for departmental projects and activities, as required. + Must be able to perform Regulatory Affairs Specialist role. + May review submissions/ applications compiled by the Regulatory Affairs Specialists. + Exhibit professional behavior with internal/external business associates, reflecting positively on the company. + Understand the quality consequences of improper job performance and is aware of potential compliance defects in their area of responsibility. + Excellent attention to detail and accuracy required. + Responsible for preparing presentations. + Interface with various levels and groups throughout the organization. + Manage multiple tasks with competing demands and deadlines. + Participate in department related projects, goals and/or objectives. **Knowledge, Skills, and Abilities:** + Knowledge of applicable laws and regulations. understanding of the regulatory requirements for licensing applications and reporting. + Ability to work independently and initiate contacts essential to submission preparation + Ability to manage multiple and possibly conflicting priorities. + Ability to work collaboratively as part of the regulatory team to meet group objectives + Ability to review a document 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 clearly communicate verbally and in writing and through professional conduct to achieve departmental objectives. + Ability to successfully interact with regulatory agencies through professional, articulate, and courteous conversations and clear, concise written communications to establish meaningful relationships. + Ability to effectively use Microsoft Office (particularly Word and Excel) and Adobe PDF to create, edit, and format documents + Ability to work with other computer systems for filing and tracking supplements and reports + Ability to meet statutory deadlines to ensure compliance, as well as business timelines to accomplish company objectives + Strong organizational skills with the ability to manage multiple tasks and prioritize effectively in a deadline driven environment. + Ability to plan ahead and foresee or handle possible barriers that may appear due to a project or in the day-to-day job. + Ability to elevate potential concerns/discrepancies to supervisors or management in a timely fashion. + Take initiative; look for opportunities to act and contribute to the team's success. + Ability to offer support by partnering with coworkers to promote an open, organized and challenging environment. + Ability to work independently with limited supervision and interact well in a team environment to complete duties as required. + Ability to think through problems clearly and logically. + Model and demonstrate high standards of integrity, trust, openness, and respect for others. + Ability to demonstrate openness to constructive feedback in order to improve on a continuous basis. + Make good use of unsupervised time. + Ability to connect individual responsibilities with company mission and department goals to meet business objectives while being a good representative of the company. + Embrace change and continuous improvement. **Education and Experience:** + Typically requires 5 years of related experience with a Bachelor's degree **Occupational Demands:** Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. **\#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** Learn more about Grifols (************************************** **Req ID:** 535306 **Type:** Regular Full-Time **Job Category:** MANUFACTURING