Quality Assurance Specialist- Pharmaceutical manufacturing
1 month ago
Job Title - Quality Assurance Specialist- Pharmaceutical manufacturing
Location – Novato, CA
Duration: 12 months
Responsibilities
- This position reports to the Quality Assurance Supervisor/ Manager/ Senior Manager and is responsible for quality oversight of one or more processes relating to make, assess, and release for products produced in Novato manufacturing facilities.
- The responsibilities in the role include the following:
- Provide quality oversight of one or more portions of operations including, but not limited to;
- Direct observation of manufacturing operation for adherence to GMP.
- Review of GMP documentation from manufacturing and/ or QC, which can include log books, batch records and test records.
- Issuance of Production Batch Record to Manufacturing
- Scanning and archiving executed production batch records
- Ensure manufacturing and QC adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations. Working knowledge of United States and European regulatory requirements, guidelines, and recommendations a plus (additional jurisdictions a plus).
- Revise QA related procedures as needed.
- Attention to detail. MS Office. Ability to operate basic office equipment, e.g. scanners, printers.
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