Quality Assurance Senior Associate

Note: Fully Onsite, Shift Work Schedule (includes weekends, and possibly nights) Once shift is determined shifts will be on a stable schedule. Must have: Manufacturing and PQA background Let's do this. Let's change the world. TheNorth Carolina (ANC) Sr. Associate Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, and commercial operations. The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance Responsibilities: • Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations. • Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations andrequirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls. • Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA)s. • Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements. • Oversee and provide guidance during on-the-floor analytical testing. • Ensure that changes that could potentially impact product quality are assessed according to procedures. • Ensure that deviations from established procedures are investigated and documented per procedures. • Alert senior management of quality, compliance, supply and safety risks. • Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation. • Identification and implementation of continuous improvement opportunities within our processes and systems. • Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.

Created: 2026-03-10