Octapharma Plasma jobs in Raleigh, NC

How to Maximize your opportunity to do rewarding work, your future leadership potential, and your career growth? Join an industry leader. [Become one, too!] Octapharma Plasma offers professional opportunities that make a meaningful difference. We enhance the lives of patients who need our life-saving medicines. We reward the donors who provide the plasma we collect to make them. And we inspire growth and development in the teams at our donation centers, offices, and labs. We invite you to do the same in this role: DONOR CENTER DIRECTOR This Is What You'll Do: Oversees donor center staff and operations, including production, quality compliance, finance, HR, and IT. Acts as a liaison with all corporate functions to ensure center compliance and performance. Maintains a thorough understanding of state and federal regulations (e.g. FDA approved Standard Operating Procedures, OSHA, CLIA, and GMP) to maintain the highest production standards and ensure facility compliance. Complies 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. Ensures that product shipments and sample submissions are accurate and performed in accordance with shipping schedules. Maintains a professional and courteous relationship with donors that will stimulate donor retention, referrals, and production growth. Ensures projected production budget is met in both quantity and potency. Trains, develops, and manages all staff in accordance with the Human Resources and company policies and other established management guidelines and regulations. Creates an organizational environment that stimulates the morale and productivity of the work force and its leadership. This Is Who You Are: A natural leader who displays strong character and integrity People person extending to a diverse group of individuals and demographics Outgoing, personable, energetic, and enthusiastic Excited to teach, learn, and advance with a growing organization Self-motivated and willing to assume the initiative Attentive, Organized, Multi-tasking, Problem solver Profession appearance and demeanor Strong communication, organizational, planning skills. Excellent written, verbal, and interpersonal communication skills. Demonstrated proficiency with Microsoft Office. Ability to work day and evening hours, weekends, holidays, and extended shifts. This Is What It Takes: Bachelor's degree preferred. Job experience will be considered in lieu of a degree. Minimum three (3) years' management/supervisory experience. Minimum three (3) years' experience recruiting, hiring, training and managing the performance of employees. Minimum one (1) year experience with responsibility for financial management and/or budgeting. Experience working in a highly regulated industry, preferred. Do Satisfying Work. Earn Real Rewards and Benefits. We're widely known and respected for our benefits and for leadership that is supportive and hands-on. Formal training Outstanding plans for medical, dental, and vision insurance Health savings account (HSA) Tuition Reimbursement Employee assistance program (EAP) Wellness program 401 (k) retirement plan Paid time off Company-paid holidays Personal time More About Octapharma Plasma, Inc. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch. Interested? Learn more online and apply now at: octapharmaplasma.com INNER SATISFACTION. OUTSTANDING IMPACT.

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** **Shift: 1st** **Summary:** The Shipper Receiver is responsible for performing the physical tasks and SAP transactions involved in the receiving, storing, and shipping of raw materials, products, equipment, and samples by unpacking and checking goods received against purchase orders or invoices, maintaining records of received goods, rejecting damaged items where necessary, and picking, packing, staging and loading temperature-sensitive finished goods for shipment to distribution partners and customers. The Sr. Shipper Receiver is responsible for performing the physical tasks and SAP transactions involved in the receiving, storing, and shipping of raw materials, products, equipment, and samples by unpacking and checking goods received against purchase orders or invoices, maintaining records of received goods, and rejecting damaged items where necessary. Processing and aggregating/de-aggregating both non-serialized and serialized customer orders, and picking, packing, staging and loading temperature-sensitive finished goods for shipment to distribution partners and customers. Also, prepares shipment documentation for export ships that is sent to the ITCL group for final export document preparation and shipment release. **Primary responsibilities for role (level-specific responsibilities should be included in the chart below):** + Unload inbound freight, verify accuracy of shipper's and carriers' counts, and verify condition of goods received. Notes any discrepancies and brings to the attention of the supervisor. Sorts and labels raw materials according to procedures. + Prepares receiving records for and delivers incoming non-inventory items to departments. Maintains files of delivery receipts for non-inventory items. + Prepares outbound freight for shipment, including marking, strapping of cases, and paperwork preparation. Picks and stages orders, while packing according to customer request using special marking and delivery, if needed. Prepares Bills of Ladings and transportation documents. Performs TSA screening in accordance with TSA protocols and Grifols policies and procedures. Prepares and places temperature monitoring devices for shipments of temperature-sensitive products. + Loads outbound freight. Obtains carrier's signatures for outbound goods. Sets up special pick up and delivery as requested. + Move on-test finished goods from packaging to B100 on-test area. Move off-test finished goods to proper storage areas. Verifies count of finished goods received to off-test document. Reports discrepancies to supervisor. + Prepare and pack frozen export paste shipments with or without dry ice in a +5 degree cold room and pack/load +15C export bulk product shipments on ocean containers. + Performs inventory counts and periodic cycle counting activities to confirm inventory accuracy for both raw materials and finished goods. + Maintains work area in a clean and safe condition and documents cGMP housekeeping logs. + Safely operate fork trucks, pallet jacks, order selector, and shuttle trucks. + Use SAP and SAP Console to perform inventory updates and serialization transactions to aggregate/de-aggregate materials at both the pallet, case, and unit level while handling finished goods shipments. This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. **Additional Responsibilities - Shipper/Receiver and Senior Shipper/Receiver** + Must be familiar with plant hazardous materials procedures. + Maintains forklift batteries to ensure proper charge and water levels. + Collects empty wooden pallets from plant corridors and moves serviceable and unserviceable pallets to the warehouse; may assist with loading unserviceable pallets for removal. + Maintains warehouse housekeeping to meet GMP requirements, including skylights, docks, etc. + Handles return goods, segregating product awaiting Quality disposition or return to stock according to procedures. + Prepares and ensures accuracy of outbound freight for shipment, including marking, strapping, paperwork preparation, and picking/packing of serialized and non-serialized orders per customer specifications. + Sets up special pick-up and delivery requests as needed. + Responsible for storage, withdrawal, and delivery of hazardous raw materials throughout the facility. **Additional Senior Shipper/Receiver Responsibilities** + Performs inventory checks and cycle counts of raw materials and finished goods to ensure inventory accuracy. + Conducts pre-loading checks for containers to confirm suitability prior to loading. + Assists in training newer or less experienced employees (e.g., Shipper/Receiver) on all aspects of the job. **Knowledge, Skills, and Abilities:** + Must pass a Security Threat Analysis by TSA for this position and it is highly recommended to start the California Board of Pharmacy course. + Must possess a valid driver's license in the state in which the employee works and meet the Qualifying Driver Criteria of the Grifols Fleet Program which includes but is not limited to a 5 year Motor Vehicle Records (MVR) lookback of major driving violations. + Requires basic computer skills. + Ability to repeatedly lift up to 50lbs. + Prolonged standing during an entire shift. + Must be able to work overtime on short notice. + Must be able to perform all basic math functions. **Education and Experience requirements** : **Shipper Receiver** + Requires high school diploma, or equivalent. + One year of pharmaceutical, chemical, food handling/distribution and/or warehouse, logistics, production manufacturing experience in a regulated industry (FDA, USDA, NRC) obtained within the last 5 years OR Two years of warehouse experience in a non-regulated industry OR Graduation from an accredited college/university with an Associate's or Bachelor's degree in: Supply Chain/Logistics, Biology, Chemistry, Biochemistry, Engineering, Pharmaceutical Technology, Business, Teaching or a related curriculum OR Completion of the Bioworks Certification Program. + Previous forklift experience is preferred. Ability to operate a forklift and obtain forklift certification within 30 days of employment is absolutely required. **Senior Shipper Receiver** + Requires high school diploma, or equivalent. + Two years of pharmaceutical, chemical, food handling/distribution and/or warehouse, logistics, production manufacturing experience in a regulated industry (FDA, USDA, NRC) OR Three years of warehouse experience in a non-regulated industry. Promotion from Shipper/Receiver to Sr. Shipper/Receiver may occur at 18 months provided the employee has completed all required training and received an "exceeds expectation" on their most recent PMP. Qualified to perform all duties associated with the Shipper/Receiver role. **Equivalency:** Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires an Associate's degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor's degree. **Occupational Demands:** Work is performed in a warehouse environment. Exposure to chemicals and moving machinery, kneeling, crawling and squatting. Works at heights on order selector and/or on ladders. Operates forklifts, tractors and power equipment. Personal protective equipment required such as protective eyewear, safety shoes, gloves and hearing protection. May walk; stand, bend and twists waist for 2-4 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Repetitive foot movement. Light to moderate lifting and carrying of 15-44lbs. for 2-4 hours per day. Heavy lifting and carrying of 45lbs.and over for 2-4 hours per day with a maximum lift of 75lbs. Exposure to cold temperatures at 41 degrees F while working in the +5 cold room. Hearing acuity essential. Depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs simple and repetitive tasks that vary little each day by following a set of written or oral instructions/procedures. Maintains work pace to meet production standards. 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:** 537120 **Type:** Regular Full-Time **Job Category:** LOGISTICS

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. Primary Responsibilities: * Participate in the development and review of the Clinical SOPs, Regulatory documents and Study Plans * Participate in the Clinical SOPs periodic reviews as well as in the creation of new procedures * Participate in the study plans reviews * Participate in the review of Regulatory Documents (Clinical Study Protocol, Investigators Brochure, Informed Consent Form, Clinica Study Report) * Provide quality oversight on the conduct of the clinical studies * Perform periodic quality reviews of the critical clinical procedures on the different clinical studies * Interact with Drug Development department to provide guidance and consultancy to resolve compliance issues * Coordinate the management of study, internal and vendor deviations * Participate in the review of critical protocol deviations and Serious Breaches * Participate in project team internal meetings providing information about quality metrics of studies * Collaborate in the development of the Quality Risk Management Assessment of the different clinical studies * Initiate the Quality Risk Assessment for every clinical study * Qualification and periodic assessment of clinical and pharmacovigilance vendors participating in the clinical studies * Perform a quality assessment (including a risk assessment) of all the vendors selected as candidates to participate in the clinical studies * Qualify the clinical vendors before their participation in the clinical studies and re-qualify them when applicable * Perform an annual assessment of the performance and compliance of the vendors participating in the clinical studies Requirements: * Life Sciences Degree. * A minimum of 5 years in a similar role or provide experience in Quality and Clinical Trials. * Ability and willingness to travel. * Ability to work both in a team and independently. * Ability to meet deadlines, multitasks, and prioritize based on study needs. * Ability to works on assignments with a diverse scope. * Ability to work with a very limited direct supervision. * Advanced knowledge of ICH/GCP Guideline. * Advanced knowledge of electronic data capture (EDC) systems. * Advanced knowledge of medical terminology. * Advanced knowledge of the therapeutic areas assigned. * Routinely demonstrates mastery of technical skills Occupational Demands Form: Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : NC-RTP:[[cust_building]]

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

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. **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

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 Senior Operations Supervisor plays a critical leadership role in the day-to-day operations of the plasma donor center. As a senior frontline leader, this role is responsible for overseeing the daily activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts as a lead resource during shifts, ensures execution of operational priorities, and provides direct support to the Center Manager in driving performance, donor satisfaction, and continuous improvement. **Primary Responsibilities** + Serves as acting leader in the absence of the Center Manager as assigned. Maintains the ability to perform any/all tasks within the plasma center; fulfill the role of production employees and supervisor donor flow + Oversees donor operations and supervise Operation Supervisor(s) and donor center staff during assigned shifts. This includes provide shift leadership, including staffing coordination, task assignments, break schedules, and coaching of team members. + Creates employee schedules to accommodate donor cycles. + Determines the adequacy and adjust inventory levels of all goods and supplies necessary of the operation of the donor center. Compile and submit orders to vendors to meet determined inventory levels + Keeps Center Manager informed of any irregularities within the center and provide action plans to improve and correct center deficiencies. + Supports and executes daily operational plans to achieve center performance targets related to donor throughput, quality, and productivity. + Partners with Center Manager and Quality team to identify and resolve deviations or operational concerns in real time. + Monitors donor flow and proactively address delays or service issues to ensure an exceptional donor experience. + Oversees donor floor operations and supervise operation supervisor(s) and donor center staff during assigned shifts. + Learns and maintains thorough familiarity and compliance with all state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP) and internal company procedures. + Supervises donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP. + Attends all required training sessions, staff meetings, etc. + Ensures that accurate and thorough documentation of necessary records is performed. + Under the guidance of the Center Manager assure facility is maintained in a neat and clean condition and all equipment is kept in good working order. + Submits timely and accurate reports as required by the Center Manager + Assists in the control of center donor funds as determined by the Center Manager + Participates in the onboarding, training, and cross-training of staff to support center agility and performance. + Maintains active communication with other service areas to ensure accurate documentation and quality. + Leads by example in promoting a culture of safety, teamwork, and accountability. + Reports all unsafe situations or conditions to area lead, supervisor or manager. + May be trained to repair plasma center equipment. + Assists the Center Manager in any task necessary in pursuit of company objectives. This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. **Education** : High school diploma or GED. Certified as a Phlebotomist, Donor Center Technician, Plasma Processor, and Designated Trainer. CPR Certified **Experience** : Typically requires 6 years of related experience with performing phlebotomy, donor processing, and plasma processing duties with demonstrated proficiency to handle difficult situations. **Equivalency** : Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires an Associate's degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor's degree. **Knowledge | Skills | Abilities** Exceptional customer service skills. Proficient in speaking and writing English, with legible handwriting. Where applicable, bi-lingual skills. Ability to understand, explain, and follow SOP's and protocols. Ability to work flexible scheduling to meet business needs. Ability to perform in a highly regulated, operations intensive, high volume medical business in which the safety of donors and employees, as well as the quality of the plasma collected, are paramount. **Occupational Demands Form # 73** : Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing functions in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves, and cold gear. Work is performed both standing for up to 4 to 6 hours per day and sitting 1 to 2 hours per day each. The position does require bending and twisting of neck up from 1 to 2 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement; may squat, crouch, or sit on one's heels on rare occasion. Infrequently bends and twists at waist. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to 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. Works independently and within guidance of oral or written instructions. Performs a wide range of tasks as dictated by variable demands and changing conditions. Relates sensitive information to diverse groups. **\#biomatusa** **\#app** **\#LI-CM1** 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:** 535681 **Type:** Regular Full-Time **Job Category:** GENERAL MANAGEMENT

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Internship Start Date: Flexible - to be determined during the interview process Schedule: Part-time during the academic year, with transition to full-time over the summer Grifols has been a leader in the healthcare industry since 1909 by creating innovative products and services based on the values of ethics, quality and responsibility. Grifols' activities focus on fulfilling the needs of its patients as well as healthcare professionals working in therapeutics, pharmacy, diagnostics and blood banking. For more than 100 years, Grifols has developed, manufactured and marketed products designed to improve human health. Grifols manufactures plasma derived biopharmaceutical products of proven efficacy, quality and safety. For more information, please visit our website:

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. **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. **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

Looking to Strengthen your positive impact on patients' lives, your level of excitement at work, and your compensation? We thrive on change. [So can you!] The role of an EMT/Paramedic at Octapharma Plasma is rewarding in every sense of the word. No two days are the same as every situation brings exciting new challenges-ones we meet with genuine empathy, skill, and enthusiasm. Our rapidly expanding organization offers the ability to enhance lives, exhilarating work, and the compensation you deserve. Join us as a: EMT/PARAMEDIC - Physician Substitute This Is What You'll Do: Perform medical evaluation of potential donors for automated plasmapheresis procedures Determine donor suitability of new applicants in consultation with a donor center physician Provide limited emergency care, including the administration of medications or treatments Determine donor suitability for new applicants Conduct evaluations to ensure compliance with criteria for normal plasma donors Maintain communication logs regarding donor suitability Review normal and abnormal blood tests to determine continued donor suitability Counsel donors with abnormal test results and defer them accordingly This Is Who You Are: An individual of strong character and demonstrated integrity A person committed to excellent customer service all day, every day Empathetic enough to understand and appreciate our donors Self-motivated and willing to assume the initiative Teachable with a desire to learn and advance Someone with positive energy, always willing to pitch in where needed Understanding, patient, and genuinely authentic Hungry to build a great career This Is What It Takes: Graduation from a recognized healthcare educational program Current licensure as an EMT Intermediate, Advanced, or Paramedic Current certification in CPR Ability to educate donors, staff, and community regarding our plasma donation program A high degree of organization, team orientation, flexibility, and comfort working with a diverse group of people within a very busy medical environment Basic computer proficiency; Microsoft Word and Excel preferred Blood bank or plasma center experience highly preferred One or more years of hospital, field care, or plasma center experience preferred This Is Why EMTs/Paramedics Love Working Here: We offer typically better pay and benefits than hospitals Our team is immersed in a setting of constant, exciting change Excellent teamwork/friendly co-workers Supportive environment Strong ethical standards Opportunities for advancement Do Satisfying Work. Earn Real Rewards and Benefits. We're widely known and respected for our benefits and for leadership that is supportive and hands-on. Managers who truly want you to grow and excel. Formal training Outstanding plans for medical, dental, and vision insurance Health savings account (HSA) Employee assistance program (EAP) Wellness program 401 (k) retirement plan Paid time off Company-paid holidays Personal time More About Octapharma Plasma, Inc. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch. Interested? Learn more online and apply now at: **************************************** And if you know someone else who'd be a great fit at Octapharma Plasma, Inc., please forward this posting along. INNER SATISFACTION. OUTSTANDING IMPACT. #ZR

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. **This is an hourly, entry-mid level position with some office exp needed.** **Plasma Process Data Analyst I** **Summary:** The Plasma Process Data Analyst maintains and prepares plasma yield and accountability reports; performs data entry using various software (i.e. Bioman, SAP, etc.) programs. He/she also prepares graphs, retrieves and verifies production data (yields and inventories); identifies discrepant data, yield trends, problem yields and provides analysis of yield data. **Primary responsibilities for role:** ● Maintains and generates a variety of reports (i.e. yield, trending, efficiency or KPIs, etc.) ● Enters data into database using various software (i.e. Bioman, SAP, Excel, etc.) ● Prepares graphs, collects and verifies production data (i.e. yield, inventory, etc.) ● Identifies discrepant data, yield trends, etc. ● Reviews process orders in order to determine what components (i.e. stoppers, etc.) are needed to meet production schedule ● Maintains inventory of production supplies (i.e. gowning or lab coats, operating and cleaning supplies, etc.) ● Prepare annual product reviews. ● May review Batch Production Records (BPRs) and SOPs for accuracy. ● Interacts with external vendors in order to secure components/supplies needed for the department. ● Other duties as assigned (i.e. projects, etc.) **Additional Responsibilities:** Alert Manufacturing if changes are made which impact BPRs. **Knowledge, Skills, and Abilities:** Requires the ability to analyze production data at various stages; May be required to interpret yield data; Must be able to work independently with a high degree of accuracy; May be able to detect inconsistencies, deviations and trends, etc. **Education:** High School diploma or equivalent. An associate's degree is preferred. An equivalent combination of education and experience may be considered. **Experience:** A minimum of two years of relevant experiences is required. Incumbent must have good written and verbal communication skills; the ability to analyze, proofread, and edit data; and possess excellent computer skills. **Equivalency:** Depending on the area of assignment, directly related experience or a combination of directly related education and exprience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires an Associate's degree plus 2 years of experince , an equivalent could include 4 years of experience or a Bachelor's degree. **Plasma Process Data Analyst II** **Summary:** The Plasma Process Data Analyst II performs all duties of the Data Analyst I and performs a thorough forecast/analytic review of materials for the production and supplies needed in Manufacturing production to aid in financial audits, component inventory levels and on low/high yields that is utilized by Senior Management to make key decisions in these areas. **Primary responsibilities for role:** ● Perform all duties of a Plasma Processing Data Analyst I. ● Investigates and provides in-depth information to Sr. Management from financial reports on low/high yeilds. ● Analyzes inventory levels in SAP/quality incoming inspection and provides direction on priority of materials to be inspected /added to priority list. ● Provides memos to the investigation group to support incident investigations and to release quarantine material. ● Reconciles variances in SAP in order to be audit ready; department lead for finance audits. **Knowledge, Skills, and Abilities:** Requires the ability to analyze production data at various stages; May be required to interpret yield data; Must be able to work independently with a high degree of accuracy; May be able to detect inconsistencies, deviations and trends, etc. Strong SAP and/or excel experience. **Education:** High School diploma plus 4 years relevant experience. An associate's degree is preferred plus 2 years experience. **Equivalency:** Depending on the area of assignment, directly related experience or a combination of directly related education and exprience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires an Associate's degree plus 2 years of experince , an equivalent could include 4 years of experience or a Bachelor's degree. Work is performed in an office and a laboratory/manufacturing environment or warehouse. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures. Recruiter - Kaleena Rozier Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.** Learn more about Grifols (************************************** **Req ID:** 535651 **Type:** Regular Full-Time **Job Category:** MANUFACTURING

Want to Expand your career-development potential, your ability to help donors and patients, and your access to professional opportunities? We're growing fast. [You can, too!] There are so many ways Octapharma Plasma can enhance your life and your career. Our strong growth is creating great learning and career development opportunities throughout our company, and especially our donation centers. Because you're someone who loves to learn, enjoys people, and has a real heart to help, we encourage you to join us as a: Phlebotomist II This is What You'll Do: * Ensures total operation is compliant with state and federal regulations (e.g. FDA approved Standard Operating Procedures, OSHA, CLIA, and GMP) to maintain the highest production standards and ensure facility compliance. * Maintains high level of customer service and positive donor experience in line with company values and culture. * Maintains cleanliness of work area to ensure a clean and professional environment. * Reviews and confirms donor identification and maintains donor confidentiality per Standard Operating Procedures. * Sets up and prepares all equipment and disposable supplies for venipuncture and plasmapheresis procedure. * Labels and ensures each unit and samples are labeled accurately. * Execute venipunctures and plasma collection, maintaining the highest standards of quality and safety. * Operates the automated plasmapheresis machines, including response and evaluation of all machine alarms and alerts, donor adverse events, document exceptions, etc. * Monitor donor conditions, employing techniques to ensure donor comfort, safety, and the quality of plasma product. * Maintains proper ratio to ensure donor safety and to quality of product. * Disconnects donors and handles the disposal of biohazardous waste and contaminated equipment, including cleaning spills and following safety protocols. * Performs daily, weekly, and monthly calibration/maintenance of automated plasmapheresis machines and removes and/or replaces equipment from service, if needed. * Reports all unsafe situations and conditions to management. * Maintains/stocks adequate inventory and replenish supplies on plasma carts. * Responsible for mentoring Phlebotomist I and may be assigned to drive training efficiencies to ensure timeliness and compliance and may be assigned as a Designated Trainer. * Responsible for troubleshooting machine alarms/alerts and perform QCs routinely (defined as daily/monthly). * Partners with Quality Assurance on overall Donor Floor performance (favorable performance observations, CAPA implementations and continuous improvement initiatives). * Assists with storage room organization and performs assigned tasks following the First In, First Out (FIFO) method. * Performs other job-related tasks as assigned. This is What It Takes: * High school diploma, or equivalent (GED) required * Any specific certification or licensing based on State requirements. * Minimum three (3) months' experience in a medical or health care environment or equivalent combination of education and experience preferred. * Must have completed documentation of training appropriate for duties, prior to performing duties independently. * Ability to speak, read, write (legibly and accurately), and understand English required. * Strong customer service skills required. * Ability to understand and follow written and verbal protocol required. * Basic computer knowledge and skills required. * Able to make accurate and complete documentation. * Ability to read and interpret documents, such as safety regulations, operating and maintenance instructions and procedure manuals required. * Ability to function effectively in a fast-paced environment with frequent interruptions. * Demonstrated consistency and reliability (good attendance, punctual, apply full effort throughout shift, flexibility with assigned schedule) required. * Ability to work daytime and evening hours, weekends, holidays, and extended shifts on a frequent basis required. * Ability to perform venipunctures required. * Effective communication skills required. * Employee possesses enhanced collaboration and adaptability skills. Do Satisfying Work. Earn Real Rewards and Benefits. We're widely known and respected for our benefits and for leadership that is supportive and hands-on. Managers who truly want you to grow and excel. * Formal training * Outstanding plans for medical, dental, and vision insurance * Health savings account (HSA) * Flexible spending account (FSA) * Tuition Reimbursement * Employee assistance program (EAP) * Wellness program * 401k retirement plan * Paid time off * Company paid holidays * Personal time More About Octapharma Plasma Inc. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch. Interested? Learn more online and apply now at: octapharmaplasma.com And if you know someone else who'd be a great fit at Octapharma Plasma, Inc., please forward this posting along! INNER SATISFACTION. OUTSTANDING IMPACT.

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. The Clinical Research Associate assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Ensures coordination of an accelerated study start-up including pre-study visits, initiation, interim, and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study. Primary responsibilities include: * Tracking study specific tasks and progress of the trial. * Performing regulatory document review and approval for IP release. * Assisting in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings). * Conducting monitor training. * Performing monitoring/co-monitoring activities for site initiation visits, interim site monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies. * Understanding and implementing processes for distribution and tracking of SAE's, safety documentation, and pregnancies. Monitors compliance of these processes. * Collaborating with data management to resolve queries. * Facilitating investigator site payments, as applicable. * Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation. * Assisting in evaluation of vendor performance during conduct of the study. * Acquiring a basic knowledge of the therapeutic area and product. * Obtaining a complete understanding of all trial-related documents and operational procedures. * Gaining exposure/participates in CRF development, IVRS set-up, central lab set-up, and other vendor selection processes. * Maintaining clinical trial management system (CTMS) information pertaining to the study as applicable * Assisting with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation). * Reviewing and tracking study documents, including: project files both electronically and in the Trial Master File and Project Status Reports. * Preparing accurate and complete meeting minutes for various meetings. * Communicating and interacting with relevant study personnel, including: develops and maintains collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to study manage; troubleshoots and follows up on study progress; and, reviews report data for completeness and accuracy. * Assists with effective and timely audit/inspection responses. For studies monitored in house by Grifols, additional responsibilities may include: * Identifies/screens/qualifies investigators through feasibility questionnaires and pre-study visits. * Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up. * Conducts/oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine protocol and regulatory compliance. * Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity. * Reconciles clinical supplies and drug accountability records at study sites. * Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required. * Reviews, clarifies, and obtains, data changes via query resolutions with site personnel. * Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to accurately and completely document site status and activities. Additional responsibilities: Leads the activities of the CRA team to meet the study objectives. Identifies and addresses weaknesses in individual or team performance. Assists study manager in overall study management. Monitors and/or co-monitors as required with CRO and CRA staff to insure study integrity and compliance. Develops ICF templates and reviews study specific ICF(s). Participates in CRF development and completion. Reviews monitoring reports and QA reports from site visits. Manages clinical study set-up and follow-up study activities through tracking and review. Assists in the development of the clinical risk management plan. Develops, implements, and maintains monitoring plan for studies run internally. Coordinates and presents at investigator meetings, kick-off meetings, etc. Interacts as functional lead with data management, safety, regulatory personnel, and other functional groups. Leads team members in reviewing data listings in reviewing data listings and writing queries. Tracks and manages the distribution of study drug and clinical supplies. Contributes to development of site budget. Knowledge, Skills, and Abilities: Excellent knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs. Excellent knowledge of therapeutic area assigned. Excellent knowledge of ICH/GCP Guidelines and EDC process. Strong verbal and written communication skills. Ability to train others in using MS Office Suite, Impact, and EDC systems. Ability to meet deadlines, multitask, and prioritize based on study needs. Ability to make sound decisions based on available information. Ability to establish rapport with site personnel/ colleagues. Ability to work both in a team and independently. Ability to facilitate team meetings and teleconferences. Ability to present at internal study team meeting(s). Ability to train and mentor junior CRAs. Ability to seek new learning opportunities within and outside of the assigned project. Ability and willingness to travel. Requirements: * Associate's degree in a life science field required. Bachelor's degree in a life science field preferred. * Typically requires 5 years of experience in clinical research, including a minimum of 2 years field monitoring experience and 3 years in lead CRA role. * Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. Occupational Demands: Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : NC-RTP:[[cust_building]]

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Summary: As a key member of the team, the incumbent will provide comprehensive technical and scientific expertise in the development, scale-up, transfer, and support of production processes for plasma-derived proteins. The role focuses on advanced purification unit operations, including but not limited to precipitation, filtration, chromatography, tangential flow filtration, formulation, nanofiltration, and process troubleshooting. The successful candidate will leverage their scientific knowledge and hands-on experience to contribute to the advancement of innovative therapies. Primary Responsibilities: Support developmental projects, clinical manufacturing, and commercial manufacturing. Assist in the development and execution of action plans to support departmental goals. Prepare procedures and technical reports independently, including data analysis and interpretation. Report technical results in internal and cross-functional team settings. Develop solutions to complex technical problems within the area of expertise. Design scientifically rigorous experiments, including the interpretation of results. Ability to execute experiments independently and in a team setting. Conduct laboratory and clinical production work using standard processing and analytical equipment. Identify and collect data on critical process attributes and/or critical parameters for scaling. Support the start-up and commissioning of equipment and processes and the implementation of new raw materials on-site. Maintain laboratory and clinical manufacturing facilities in accordance with procedures. Knowledge Skills and Abilities: Possess the ability to set and meet deadlines, multitask, and prioritize personal objectives based on project needs. Exhibit the ability to adapt to a changing work environment. Have experience in technical writing and effective oral communication skills. Apply scientific or engineering principles to problem-solving. Be adept at working at various process scales, ranging from bench to pilot scale. Have knowledge and experience working in a GMP environment. Takes initiative to stay current in area of specialization (e.g., chromatography, filtration) and expand knowledge base. Be self-motivated and able to work effectively in a matrixed organization. Be proficient in using the MS Office Suite. Location: Clayton, NC Shift: Day Education and Experience: Senior Associate Process Development Engineer I Level: Bachelor's degree in a relevant science or engineering field with 4+ years of relevant work experience, Associate's degree with 6+ years of experience, or an equivalent combination of education and experience. Occupational Demands for Engineer: Work is performed in a clinical and/or laboratory environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to chemicals. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits and bends neck for 4-6 hours per day. May stand and twist neck for 2-4 hours per day. Occasionally walks, bends and twists waist and squats. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Moderate lifting of 15-30lbs. with a maximum lift of 35 lbs. May reach above and below shoulder height. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently works with diverse groups to obtain consensus on complex issues. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton Learn more about Grifols

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. **Summary:** Implement worldwide regulatory product registration strategies, prepare complex registration dossiers, establish and maintain tracking of product registrations to determine what products can be shipped to intended markets in accordance with business plan with a specific focus on labeling, labeling requirements, and implementation. Coordinate and submit all regulatory documentation for establishment of new / changed local market authorization holders and distributors. **Primary Responsibilities:** + Act as Regulatory Affairs authority for key product registrations with a main focus in labeling and labeling related activities. + Analyze and determine worldwide product registration requirements for specific assigned products and regions. Implement worldwide regulatory registration strategy, communicate and negotiate with local market authorization holders/ distributors / regulatory authorities the information required and prepare regulatory submissions to be used worldwide for all marketed products. + Prepare complex registration dossiers, local application forms; negotiate documentation required for worldwide markets which may include product custom clearance documentation and coordinate with International Customer Service, Quality and Commercial preparation of required documentation in accordance with local requirements. + Prepare responses to regulatory agency inquiries. + Coordinate with local authorities and Quality standards and controls required for product registration testing. + Represent the regulatory function in communication with outside companies, customers and regulatory authorities. Responsibilities may include preparation and presentation (if required) to regulatory authorities. (e.g. labeling specific projects). + Represent the regulatory function on project teams as related to worldwide product registrations. Provide information that is presented to, for example, the Peer Review Committee, the Site Leadership Team and the Quality Management Review to enable informed decisions. + Collaborate with all disciplines to assure appropriate testing and documentation are generated for regulatory submissions and routine import documentation. Prepare personnel from affiliates or third parties for meetings with regulatory authorities. + Coordinate and interact with domestic and international regulatory counterparts to obtain input regarding regulatory considerations and decisions to formulate regulatory strategy for changes to products/facilities/equipment with an impact on product labeling. + Request and obtain all required FDA export documentation required for registration and routine product shipments. + Evaluate impact of new labeling regulatory requirements as well as evaluate changes to existing product labeling on assigned projects and products and inform other departments as necessary. + Maintain worldwide product registration status and distribute routine updates to commercial, sales and Quality to determine where registered products can be marketed. + Mentor and support the professional development of staff. + Perform other duties as required. **Knowledge, Skills, and Abilities:** + Ability to prioritize and initiate contacts essential to labeling submission preparation. + Ability to work independently and initiate contacts essential to create labeling components for submission preparation while ensure technical information is accurate. + Knowledge of product and labeling history to maintain consistency within a product line and within the product portfolio labeling. + Ability to clearly communicate verbally and in writing with internal and external contacts that may include industry representatives, affiliates, third parties and regulatory authorities in various countries. + Ability to work with management of other Grifols departments to achieve common business goals as well as regulatory objectives. + Ability to review a document, including labeling, in detail to ensure accuracy based on regulatory requirements, and to ensure the use of the appropriate forms, format, content, and authorized signatures. + Ability to effectively use Microsoft Office (particularly Word and Excel) to create, edit, and format documents + Ability to work with other computer systems for filing supplements and reports. + Ability to interpret and effectively communicate regulatory requirements internally as well as to distributors/affiliates with a specific focus in labeling. + Ability to successfully interact with external contacts which may include worldwide distributors / Grifols affiliates / regulatory agencies through professional, articulate, and courteous conversations and clear, concise written communications. + Ability to meet statutory deadlines to ensure compliance, as well as business timelines to accomplish company objectives. **Preferred Background:** + Advanced degree with clinical experience + Experience working on global labeling initiatives and submissions + Familiarity with electronic labeling systems and regulatory publishing tools + Demonstrated leadership in cross-functional team settings **Minimum Requirements:** **Sr. Specialist II** + Bachelor's degree in relevant discipline, or equivalent work experience industry regulatory experience. + Minimum 5 years of related technical and/or regulatory experience in pharmaceutical industry or an equivalent combination of education and experience. + Experience with biological products related to but not limited to facilities, validation, environmental monitoring, cGMP manufacturing, QA/QC for biological products, compliance and/or regulatory is required. + Excellent written and verbal communication skills. + Knowledge of applicable laws and regulations **Manager** + Bachelor's degree in relevant discipline, or equivalent work experience industry regulatory experience. + 6 to 7 years related technical and/or regulatory experience in pharmaceutical industry, or an equivalent combination of education and experience. + Extensive knowledge of applicable worldwide regulatory product registrations laws and regulations. + Excellent verbal and written communication skills Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.** **Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton** Learn more about Grifols (************************************** **Req ID:** 535067 **Type:** Regular Full-Time **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. **Plasma Classification Certified Inspector** **1st Shift - Monday - Friday 5:00am - 1:30pm** Position requires scanning and removal of unsuitable plasma units utilizing the Plasma Management System (SGP). A visual inspection of plasma units is also performed, removing any units which are unacceptable (e.g. damaged, broken port/tube, RBC, or backup sample rejections). Employee must be able to perform secondary verifications and Perform end of PU line clearances. **Responsibilities** + Scanning of plasma units assigned to a PU utilizing a barcode reader. + Scanning of archive samples assigned to a SA utilizing a barcode reader. + Transferring units to a Sub-shipment during the PU process. + Entering "Statistics" during the PU process. + Sub-shipment verification at the end of the PU process. + "Blocking" of units which do not meet customer requirements. + Responsible for various rejections found during visual inspection. + Removal of unsuitable plasma units marked for removal in SGP during the PU process. + Able to maintain record accountability. + Able to perform job duties with minimum supervision. + Ability to follow written procedures. + Monitoring plasma time out of freezer + Department housekeeping and safety practices + Processing of unsuitable plasma units during any step of the plasma process. + Transfer of unsuitable plasma units (status 100) to correct reject inventory + Transferring units between PU/LOT to a PU. + Ability to consistently meet department average throughput. + Knowledge of SGP Status codes and Disposition Codes. + Knowledge of labeling Requirements. + Scanning of case/units to a 3rd party sale utilizing Disposition Module. + Scanning of case/units to a MDO process utilizing Disposition Module. + Completing the partial PU cases between PU's. + Line Clearance at the end of a Plasma Process. **Requirements** + High School diploma or equivalent. + Two years' experience in Manufacturing, Pharmaceutical or other FDA licensed Industry is desirable. + Knowledge of cGMPs and Industry Standards. + Ability to follow "Standard Operating Procedures". + Possess good verbal and written communication skills. + Possess basic math skills (addition, subtraction, division, multiplication). + Basic Computer skills. **Occupational Demands** Work is performed in a manufacturing environment with rotating shifts. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to chemicals, electrical manufacturing equipment, hand tools and moving machinery. Exposure to high levels of noise and to extreme cold below 32*. Occasional entry into confined spaces requiring kneeling and squatting. Operates forklifts, tractors and power equipment. Personal protective equipment required such as protective eyewear, safety shoes, gloves and garments. Work is performed standing and walking for 6-8 hours per day. Bending and twisting neck and waist for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement. Frequent moderate lifting and carrying of 15-44lbs. Frequent heavy lifting and carrying of 45lbs. with a maximum lift of 50lbs. Occasionally reaches above and below shoulder height. Hearing acuity essential. Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently performs simple and routine tasks that vary little each day by following a set of written or oral instructions/procedures. **We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years - we're growing, and you can grow with us!** \#BiomatUSA Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.** **Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton** Learn more about Grifols (************************************** **Req ID:** 537774 **Type:** Regular Full-Time **Job Category:** MANUFACTURING