QC Microbiologist

About the role

A Quality Control (QC) Microbiology Supervisor oversees daily microbiology laboratory operations and a team of analysts. They ensure all testing—such as sterility, bioburden, endotoxin, and environmental monitoring—complies with strict adherence to the GMP regulations. This role spans method validation, root-cause investigations, and data integrity verification.

Responsibilities

• Scheduling, conducting OOS (Out-of-Specification) investigations, and managing staff training scheduling
• Congducting investigations, and managing staff training
• Supervises routine testing, including sterility testing, bacterial endotoxins (BET), bioburden, microbial limits, and growth promotion of media
• Support assay method verification, transfer, and equipment qualification within the Laboratory
• Act as a subject matter expert (SME) during internal audits and regulatory inspections
• Lead Out-of-Specification (OOS) investigations, initiate Corrective and Preventive Actions (CAPA), and implement change controls

Core Responsibilities

• Team Leadership & Development: Supervise, train, and mentor laboratory analysts. Manage scheduling, performance evaluations, and gowning/aseptic qualifications.
• Testing Oversight: Oversee and review routine microbiological assays, including sterility, bioburden, bacterial endotoxins (LAL), microbial identification (e.g., MALDI-TOF), and water testing.
• Environmental Monitoring (EM): Approve EM data, analyze trending reports, and monitor classified cleanroom utilities to maintain compliance.

Qualifications & Requirements

• Education: Bachelor’s degree in microbiology, Biology, or a closely related life science discipline.
• Experience: Minimum 5 years of hands-on experience in a cGMP pharmaceutical or biotech microbiology laboratory, including at least 3 or more years in a lead or supervisory capacity.
• Technical Skills: Advanced understanding of aseptic processing, cleanroom behaviors, and compendial requirements (USP, EP, JP).
• Soft Skills: Strong problem-solving, data trending capabilities, and excellent verbal and written communication skills.