Quality Associate II/III (2nd Shift)

GRIFOLS, S.A. • Clayton, NC

128d

About The Position

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 & 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 release and shipment of Contract Fractionation batches and Quarantine of intermediates.

Requirements

• BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 2 years relevant experience for Quality Associate II
• BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 3 years relevant experience for Quality Associate III
• Excellent communication skills (written and verbal)
• Attention to detail
• Ability to be flexible and adapt to sudden changes in priorities and deadlines
• Ability to multi-task and work well under time constraints
• Demonstrate consistent application of technical knowledge
• Basic knowledge/understanding of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines

Nice To Haves

• Knowledge of plasma release, pooling and/or fractionation processes
• Experience reviewing and approving others’ work such as batch records, test data, reports etc.

Responsibilities

• 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
• 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

What This Job Offers

• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees