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.

RESPONSIBILITIES

• Provides Quality oversight of Production activities, including compounding, aseptic filling, inspection, and labeling/packaging on the floor.
• Provides Quality oversight of cleaning activities to ensure compliance with cleaning requirements.
• Product label review and approval.
• Oversight and confirmation compliance with Filling Operations, including line clearance, material status, aseptic technique, in-process quality attribute testing, documentation on forms, and batch records.
• Verification of proper gowning by all personnel in all areas of Production.
• Generation of deviations, issuance of CAPAs, and Change Controls in response to observations.
• Oversee all Quality aspects on the floor.
• Participate in regulatory audits if required.
• Performs or assists process owners with the root cause analysis.
• Responsible for generating deviations and change controls when required.
• Performs duties following established company procedures and policies; performs other duties as assigned.

QUALIFICATIONS

• 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. BS in the Scientific field preferred
• 3 years of experience with aseptic drug product manufacturing is required.
• A fundamental, working knowledge of safety, quality systems, and quality assurance concepts are required, including the application of current Good Manufacturing Practices and Good Documentation Practices.
• Strong familiarity with manufacturing processes, operations, automation, and equipment/facilities.
• Ability to complete tasks with little direction or need for supervisory follow-up.
• Strong written, verbal, and presentation communication skills.
• Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel).
• Ability to think creatively in confronting new issues and pursuing novel approaches to old problems.
• May work with hazardous materials and chemicals
• Cleanroom environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no makeup or jewelry can be worn when working in the clean room environment
• Specific vision abilities by this job include close vision, depth perception and ability to adjust focus