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Specialist, Quality Assurance
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Full-time
- The Specialist, Quality Assurance provides Quality Assurance support for GMP Raw Materials that support the production of GMP Manufacturing operations of cell therapy products at our US Cell Therapy facility located in Princeton, NJ. Responsibilities include providing QA oversight of materials used for Manufacturing, Quality Control, and Process & Analytical Development.
- Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products.
- Performs line clearance and QA on the floor activities; Review and dispositions batch records; Works with Materials Control to quarantine and disposition all GMP materials in a timely manner; Review and approve Deviations/Change Controls/CAPAs; Scanning and ancillary filing.
- Assists with the generation and/or revision of GMP documentation such as Standard Operating Procedures as it pertains to the disposition of Raw Materials.
- 5+ years' experience within the biologic, biopharmaceutical, or regulated industry; 3+ years' experience in Manufacturing/Quality Assurance/Quality Control function preferred
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