Quality Assurance Operations Supervisor

Reports To: Senior QA Operations Manager

What You'll Do: Supervise, coach, schedule, and develop a team of 4 to 5 QA Technicians and QA Associates supporting daily manufacturing operations. Spend approximately 90% of working time on the manufacturing floor, providing real‐time QA support, operational verification, line clearance, and in‐process oversight. Provide QA oversight for aseptic formulation, compounding, filling, visual inspection, packaging, and related pharmaceutical manufacturing operations. Perform routine production‐floor walkthroughs and audits in ISO 8 cleanroom environments to verify compliance with SOPs, cGMP requirements, safety standards, and Good Documentation Practices. Review batch records in real time for accuracy, completeness, traceability, and compliance with ALCOA+ data‐integrity principles. Resolve documentation discrepancies and support timely completion and transfer of batch records to minimize release cycle delays. Act as the primary QA contact for on‐floor deviations, ensuring prompt documentation, initial risk assessment, appropriate containment, and escalation of critical events. Support deviation investigations using structured root‐cause analysis tools, including 5 Whys and Fishbone analysis. Partner with Manufacturing, QC, Microbiology, Validation, and other cross‐functional teams to resolve quality issues while protecting product quality and compliance. Support environmental‐monitoring activities, assess excursions in real time, and coordinate appropriate responses with Manufacturing and Microbiology. Ensure compliance with aseptic technique, gowning practices, cleanroom behavior, and validated manufacturing procedures. Support Aseptic Process Simulations/media fills, including documenting and reviewing interventions. Monitor and report quality performance indicators, including batch‐record error rates, right‐first‐time performance, and review‐cycle timelines. Serve as a frontline QA representative during internal audits, client audits, and regulatory inspections. Maintain inspection readiness and promote a strong quality culture across manufacturing operations.

Preferred Qualifications: Experience in sterile, aseptic, injectable, parenteral, biologics, or other high‐risk pharmaceutical manufacturing environments. Experience supporting environmental monitoring, sterility assurance, cleanroom qualification, or microbiological excursions. Experience with SCADA or other manufacturing‐monitoring systems. Experience supporting media fills, aseptic interventions, visual inspection, packaging, or batch release operations. Background in a multi‐product CDMO environment. Experience serving as a subject‐matter expert during FDA, client, or internal quality audits.