Second Shift QA Manufacturing Specialist

The hours for this role are 3pm to 1:30am

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

• 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 & 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
• BS in the Scientific field preferred

• Three-plus 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, and others must be able to learn additional software as required).
• Ability to think creatively in confronting new issues and pursuing 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.
• Work schedule flexibility.