Quality Assurance Associate I In Plant Operations
CurrentCollaborate in the resolution of issues associated within ISO classified manufacturing operations to provide guidance and facilitate the resumption of activities post deviation detection.Review of executed manufacturing batch records for completeness, compliance with cGMP and OSHA regulations, and accuracy to support product lot disposition.Approve the cleaning and Product Change Over (PCO) of equipment and area operations.Support approval and issuance of Batch Record Request Forms (BRRFs) and Master Batch Records (MBRs).Approve calibration and maintenance records for GMP operations.Review and approve the issuance of molecule vial pull and transfers.Review and approve quality system documents such as SOPs and Work Orders.Participate in process improvement activities aimed to add efficiency to Quality processes.