Supervisor, Quality Control – Microbiology

• 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

• Bachelor’s degree in Life Science or Biology
• At least 4 years of experience in a cGMP environment
• Bio Work 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 Track Wise 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

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.

• Leadership in QC Microbiology
• Environmental Monitoring Expertise
• CAPA Management
• Data Integrity (ALCOA+)
• CGMP Compliance

• 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

• Strong Communication
• Cross-Functional Collaboration
• Prioritization
• Leadership

• Bachelor’s Degree in Life Science or Biology
• Bio Work Certificate

• CGMP
• FDA Compliance
• EMA Compliance
• ICH Guidelines
• EU Annex 1
• ISO Standards
• Environmental Monitoring
• Microbiology
• Quality Control
• Data Integrity

• LIMS
• ELN
• Track Wise
• MS Office
• Teams