QA Inspector (3pm-11:30pm)

Job description

Nature and Scope This position is responsible for providing Quality oversight in manufacturing areas including, but not limited to Formulation, Filling, Inspection, Equipment Prep and Packaging through the execution of site policies and procedures, programs, and work instructions. This position ensures all processes and products meet specifications and that products are produced in accordance with cGMP requirements. The QA Inspector maintains compliance with quality programs. Essential Duties and Responsibilities: All inspections are conducted in compliance with the Code of Federal Regulations (CFR 211.134) Drug product inspection. Achieve and maintain Aseptic Processing Area (APA) gown qualification. Adhere to all SOP related to working in an aseptic environment, including volume/weight checks of product filled in vials and ampoules; s well as the monitoring of personnel Aseptic Technique. Checks product lot number information, documents in the batch record where applicable, and reviews Master Batch Records for accuracy at all stages in the manufacturing process - Formulation, Filling, Inspection, and Packaging. Conducts product in-process inspections at designated intervals. Dete...