Quality Control Supervisor

Lead, supervise, coach, and develop 6–12 QC Microbiology analysts Manage scheduling, training, performance feedback, and career development Maintain team qualification matrices and ensure training is current and effective 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 microbiological methods Review and approve data, test records, LIMS entries, and certificates of analysis Ensure ALCOA+ data integrity Manage sample logistics, inventory, and equipment readiness, including calibration and preventive maintenance Lead or approve QC Micro deviations, OOS/OOT, 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 new equipment qualifications Ensure compliance with FDA/EMA/PMDA/MHRA, USP/EP/JP, ICH, and EU Annex 1 requirements Host or support internal and external audits and maintain an inspection-ready laboratory Requirements Bachelor’s degree in Life Science or Biology At least 4 years of experience in a cGMP environment BioWork certificate preferred Experience with environmental monitoring in ISO/Classified spaces and utilities testing Experience with sterility testing, endotoxin/LAL, bioburden/microbial limits, growth promotion, microbial identification, AET/MVT, and data trending Experience with deviation/OOS/OOT investigations, root cause analysis, and CAPA management Familiarity with LIMS/ELN and TrackWise or similar eQMS Proficiency with MS Office/Teams Knowledge of cGMP, data integrity (ALCOA+), ICH Q7/Q9/Q10, USP/EP/JP, and EU Annex 1 (2022) Strong leadership, prioritization, communication, and cross-functional collaboration skills Ability to operate in a fast-paced, shifting-priority environment and make sound, risk-based decisions Ability to work in an environment that may necessitate respiratory protection Ability to discern audible cues Ability to perform tasks with 20/20 corrected vision and distinguish color Ability to ascend or descend ladders, scaffolding, and ramps Ability to stand and sit for prolonged periods of time (240 minutes) Ability to perform repetitive motions using wrists, hands, and/or fingers Ability to move objects up to 33 lbs Ability to bend, push, pull, reach, and use twisting motions Ability to work in warm/cold environments ranging from 0–100°F Core Competencies Demonstrates expertise in leading and developing QC Microbiology teams while ensuring compliance with regulatory standards and maintaining data integrity. Proficient in environmental monitoring, microbiological methods, and CAPA management within a cGMP environment. Highest-signal resume keywords Leadership in QC Microbiology Environmental Monitoring Expertise CAPA Management Data Integrity (ALCOA+) CGMP Compliance Hard Skills Microbial Identification Sterility Testing Endotoxin/LAL Testing Deviation/OOS/OOT Investigations Risk Assessments Lean/Six Sigma Tools LIMS/ELN Proficiency Data Trending SOP Development Validation/Qualification Soft Skills Strong Communication Cross-Functional Collaboration Prioritization Leadership Certifications & Qualifications Bachelor’s Degree in Life Science or Biology BioWork Certificate Industry Keywords CGMP FDA Compliance EMA Compliance ICH Guidelines EU Annex 1 ISO Standards Environmental Monitoring Microbiology Quality Control Data Integrity Tools & Technologies LIMS ELN TrackWise MS Office Teams #J-18808-Ljbffr