Batch Release Auditor

Job description

Overview Position Overview: The Batch Release Auditor is accountable for ensuring the conformance of the manufacturing and packaging processes to the current Good Manufacturing Practices (cGMPs), company policies and internal procedures. Performs in process GMP audits, documentation review and final release of finished product that meets established specifications. Responsibilities: Specific Responsibilities: - Partners with the departments to solve potential compliance issues in a proactive way to deliver product on time - Establish recommendations and decisions to prevent process and/or product deviations; Failure to effectively perform this role could result in product recall and/or product delays - Audits all batch records prior to disposition and/or review necessary documents to support product; Release product to market that is compliant to internal, local, state and federal regulations - Strive to improve process inefficiencies to maintain batch records to improve efficiencies - Ongoing maintenance of record retrieval system in tandem with QA staff - Demonstrates comprehensive, site-specific knowledge of all manufacturing processes (e.g., Soft Gel, Solid Dosage, Bulk Packagi...