Specialist, Quality Assurance - Hybrid
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About The Position
The Specialist, Quality Assurance is accountable for review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply drug product manufacture, testing, release and maintenance of our Company’s clinical supply programs. This person will also review and approve documentation accompanying the disposition of excipients, components, and critical supply items for sterile or non-sterile use to ensure conformance to appropriate regulatory and company requirements for clinical supply manufacture and/or regulatory inspections. Independently performs routine audits of batch documentation, data, information, procedures, equipment and systems, and/or facilities to ensure the compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and other applicable worldwide regulations and our Company procedures. Collaborates with the Quality Program Lead to issue reports summarizing results, works with area to ensure resolution of audit findings, and notifies relevant management of unresolved issues/trends. The Specialist will become knowledgeable in regulatory requirements, cGMPs and our procedures to assure clinical drug product manufacture is in compliance and will gain competency in their responsibilities.
