Quality Associate II​/III; QA Fractionation Batch-Release

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

Shift:
First Shift

Summary:

The Quality Associate II/III provides routine technical support for various tasks, assignments, and projects in the QA Fractionation business unit. This includes release and shipment of Contract Fractionation batches, pre‑pooling release of plasma pool shipments, assessment of plasma post donation & lookback 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 Quarantine of intermediates.

Responsibilities include:

• Collects, reviews and may analyze data
• Makes decisions within a well‑defined area that may influence the department goals
• Coordinates work assignments
• Addresses and resolves problems according to written procedures (eg. SOP) or practice
• Communicates effectively and promptly
• Demonstrates high levels of values and integrity
• Follows cGMP and department safety practices
• May train other employees

Additional responsibilities may also include:

• 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 function 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

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. He/she must have the ability to multi‑task, work well under time constraints, and demonstrate consistent application of technical knowledge. He/she 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 Quality release, pooling and/or fractionation processes and/or experience reviewing and approving others’ work such as batch records, test data, reports etc.

Required Education

Quality Associate II : BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 2 years relevant experience, or equivalent combination of education and experience.

Quality Associate III : BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 3 years relevant experience, or 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.

Location: NORTH AMERICA : USA : NC-Clayton:

USNC
0002 - Clayton

Learn more about Grifols ()

Req : 538978

Type: Regular Full-Time

Job Category: MANUFACTURING