Product Quality Assurance Manager

The Product Quality Assurance Manager is responsible for supporting Quality Assurance Operations at August Bioservices. The PQA Manager dispositions all products manufactured and packaged at the site and manages the team responsible for the AQL / Quality‑On‑The‑Floor Program. Successful candidates will be a team player and have exceptional communication skills, a concern for excellence, ability to develop and mentor a team, and a high ability to collaborate with various levels of the organization.

• Represent the QA department on internal and external meetings related to the release of batches ensuring quality requirements are met.
• Disposition of batches manufactured: track batch release, and partner with other departments to close out all required deliverables to support disposition (including but not limited to executed batch records, deviations, change controls, and environmental monitoring investigations).
• Ensure processes are executed according to batch records and procedures. Ensure any potential compliance issues identified during batch record review are corrected and clarified.
• Collaborate with planning groups to prioritize critical lot disposition and monitor schedule so operations have all required releases to avoid downtime.
• Review and approve batch records and labels. Review change controls, deviations, CAPAs, and environmental monitoring investigations related to production.
• Communicate lot disposition pending issues to senior management.
• Develop, implement, coordinate, administer, and continuously improve the Quality Assurance AQL Visual Inspection / On‑The‑Floor program.
• Lead quality oversight of the visual inspection / quality on the floor program.
• Manage the quality assurance team responsible for AQL/Quality‑On‑The‑Floor.
• Partner with manufacturing and other internal groups to establish a philosophy for visual inspection and develop the visual inspection qualification for operators and QA AQL specialists.
• Develop strategy on how to achieve required work, work with manufacturing to determine schedule and support, ensuring appropriate coverage which may include some evenings.
• Lead client audits and regulatory inspections, providing support during internal audits.
• Adhere to company policies and applicable regulatory agency requirements (ICH, FDA, etc.) to ensure compliance.
• Communicate clearly with cross‑functional teams.

• Master’s Degree and 5+ years’ experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility OR Bachelor’s Degree and 7+ years’ experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility OR High School Degree and 11+ years’ experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
• Must have proven track record with batch disposition activities.
• GMP compliance knowledge including 21
  
  CFR
  210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing and Part 11 compliance knowledge preferred.
• Root Cause Analysis Tools, Risk Management, Technical Writing, Microsoft Office applications, eQMS and LIMS systems, preferred.
• Work occurs in a fast‑paced environment. Individual must be able to efficiently prioritize own work as well as the work of their team.
• Experience in managing a team.

• Ability to safely wear and work in a PAPR hood and associated equipment weighing approximately 2 to 3 pounds during assigned tasks.
• Ability to perform sustained physical activities, including standing, walking, bending, reaching, lifting, and handling manufacturing equipment while wearing required respiratory protection and personal protective equipment (PPE).
• Ability to wear and operate a Powered Air‑Purifying Respirator (PAPR) for extended periods, up to 4 to 6 hours per shift, while performing manufacturing, equipment cleaning, and sanitization activities.
• Ability to wear required PPE, including pharmaceutical gowning, respiratory protection, safety glasses, chemical‑resistant gloves, and additional protective equipment as required by operational and safety procedures.

August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.