Quality Control

• Lead and supervise a team of 6–12 QC Micro analysts
• Manage scheduling, training, performance feedback, career development, and team qualification matrices
• Oversee environmental monitoring and utility programs, including viable/non-viable monitoring, compressed gases, WFI/PW, and clean steam
• Ensure timely and compliant execution of compendial and in-house microbiology methods
• Review and approve data, test records, LIMS entries, and COAs while ensuring ALCOA+ data integrity
• Manage sample logistics, inventory, and equipment readiness, including calibration and preventive maintenance
• Lead or approve QC Micro deviations, OOS/OOT investigations, environmental monitoring excursions, and product impact assessments
• Author and implement CAPAs and change controls
• Contribute to risk assessments, trend reports, stability/annual product review inputs, and APR/PQR
• Maintain and improve SOPs, methods, and validation/qualification documents
• Partner with Manufacturing, Validation, and Facilities on contamination control, cleanroom behavior, gowning, cleaning/disinfection, and aseptic interventions
• Support media fills, aseptic qualifications, and Annex 1 compliance initiatives
• Drive throughput, right-first-time, and turnaround-time improvements using Lean/Six Sigma tools
• Support or lead rapid microbiology method implementation, LIMS/ELN upgrades, and equipment qualifications (URS, IQ/OQ/PQ)
• Ensure compliance with FDA/EMA/PMDA/MHRA, USP/EP/JP, ICH, and EU Annex 1 requirements
• Host or support internal/external audits and maintain an inspection-ready laboratory

Quality Control jobs in North Carolina

Quality Control Supervisor, Microbiology