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Quality Assurance Specialist
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- Job Family: Clinical Trial Operations (Digital) Travel Required: None Clearance Required: Ability to Obtain NACI What You Will Do: - Review records related to the general operations of a Pharmacy clean room - Provide Quality Assurance input and oversight in aseptic processing/compounding facilities within the NIH. - Provide on-the-floor QA oversight in the cleanroom and support to ensure compliance to GMP regulations and USP guidance throughout those areas.
- Ensure timely resolution and escalation of issues within the operational areas.
- Support the maintenance of the Corrective and Preventive Action (CAPA), Deviation, Environmental Excursion, Investigations, and Change Control programs.
- Conduct vendor qualification programs to support aseptic processing/compounding facilities within the NIH. - Receive, log, and release incoming supplies and material to the cleanroom.
- Support the maintenance of the document control system, including formatting, numbering, and scanning of records into the Document Management System (DMS).
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