Quality Associate

Job Description 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 Quality Associate II/III provides routine technical support for various tasks, assignments, and projects in the QA Fractionation business unit. This includes pre‑pooling release of plasma pool shipments, assessment of plasma post‑donation & look‑back alerts, preparation of pool sample shipments to the PEI, and manufacturing record review for Pooling through Fractionation Batch Release to support department cycle time goals. Other tasks performed by the Quality Associate II/III may also include those associated with release and shipment of Contract Fractionation batches and quarantine of intermediates. Responsibilities Collect, review, and may analyze data Make decisions within a well‑defined area that may influence department goals Coordinate work assignments Address and resolve problems according to written procedures (e.g., SOP) or practice Communicate effectively and promptly Demonstrate high levels of values and integrity Follow cGMP and department safety practices May train other employees Additional responsibilities Execute assignments of medium complexity Develop solutions to defined problems Collect, review and analyze data to generate department reports Communicate effectively at all levels of the organization, supporting department objectives and management decisions Perform roles and/or tasks associated with one or more Quality System functions such as Batch Release, SAP Quality Module, Documentation, Change Control, Discrepancy Management, Quarantine, and Annual Product Reviews May also provide Quality support for validation, capital projects, ETPs, regulatory submissions, or other studies Work Environment Some tasks will be performed in a gowned, classified area including in +5° C or colder environments. Knowledge, Skills, and Abilities Successful candidates should have excellent communication skills (written and verbal), attention to detail, and the ability to be flexible and adapt to sudden changes in priorities and deadlines. They must be able to multi‑task, work well under time constraints, and demonstrate consistent application of technical knowledge. They should also have basic knowledge/understanding of domestic (i.e., Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines. Preference will be given to candidates with knowledge of plasma release, pooling and/or fractionation processes and/or experience reviewing and approving others’ work such as batch records, test data, or reports. Required Education Quality Associate II (M06): BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 2 years relevant experience, or an equivalent combination of education and experience. Quality Associate III (M07): BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 3 years relevant experience, or an equivalent combination of education and experience. 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. #J-18808-Ljbffr