2nd Shift QA Manufacturing Specialist

Job Summary This position will ensure that the operations follow the cGMP standards promulgated under Section 503B of the US Food, Drug & Cosmetic Act. The QA Manufacturing Specialist will provide quality oversight of the manufacturing and production areas, including compounding, filling, inspecting, and labeling/packaging. Management includes the periodic review of in-process activities such as cleaning, weighing, aseptic filling, material status verification, compounding, batch record documentation accuracy, logbook documentation accuracy, and room/line clearances. Core Responsibilities Provide quality oversight of production activities, including compounding, aseptic filling, inspection, and labeling/packaging on the floor. Oversee quality of cleaning activities to ensure compliance with cleaning requirements. Review and approve product labels. Confirm compliance with filling operations, including line clearance, material status, aseptic technique, in-process quality attribute testing, documentation on forms, and batch records. Verify proper gowning by all personnel in all production areas. Generate deviations, issue CAPAs, and implement change controls in response to observations. Oversee all quality aspects on the floor. Participate in regulatory audits when required. Assist process owners with root‑cause analysis. Perform duties following established company procedures and policies; perform other duties as assigned. Qualifications & Requirements 3‑5 years of progressive experience in cGMP quality operations and FDA regulations, a 503B outsourcing facility, aseptic/parenteral manufacturing/development environment, or equivalent technical experience. High school degree required; BS in a scientific field preferred. Three‑plus years of experience with aseptic drug product manufacturing required. Fundamental knowledge of safety, quality systems, and quality assurance concepts, including current Good Manufacturing Practices and Good Documentation Practices. Strong familiarity with manufacturing processes, operations, automation, and equipment/facilities. Ability to complete tasks with minimal direction or supervisory follow‑up. Strong written, verbal, and presentation communication skills. Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel, etc.) with ability to learn additional software as required. Creative problem solving and ability to confront new issues and pursue novel approaches to old problems. Ability to work under pressure, meet deadlines, and exercise sound business judgment with critical thinking skills and high ethical standards. Position Details Schedule: 3 pm – 1:30 am. Hours: Full‑time, on‑site; may vary from several hours before opening to several hours after closing, with possible weekend hours, rotating shifts, and holiday work depending on workload. Location: Ledgewood, NJ. Travel: Up to 5 %. Equal Employment Opportunity As set forth in Harrow, Inc.’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. #J-18808-Ljbffr Harrow, Inc.