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Quality Assurance Operations Specialist
1 month ago
Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
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 their manufacturing facilities.
- 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.
Qualifications:
- Associates Degree required, Bachelor's Degree preferred
- Attention to detail
- MS Office
- Ability to operate basic office equipment