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QA Specialist
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- Develops and manages the QA and QC system in a regulated radiopharmaceutical environment with regards to U.S. FDA cGMP and international regulations.
- Assists in all activities to verify that appropriate, current procedures are followed, and keeps the General Manager and other designates fully informed, through verbal and written reports on the status of QA projects and QC. This person also manages deviations, Out-of-Specification results, change control requests, customer complaints, customer and internal audits, regulatory authorities' inspections, training of personnel and certifications for the Boston facility.
- Develops the QA and QC system under the guidance of the General Manager and in coordination with global head office.
- Authors, reviews, and approves of Standard Operating Procedures (SOPs) and further cGMP documents.
- Assures compliance with the company Quality Assurance and Quality Control systems.
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