Quality Control Analyst (Microbiologist)

About the role

The Microbiologist is responsible for performing microbiological testing of raw materials, water, environmental monitoring samples, in-process materials, and finished dosage forms in compliance with current Good Manufacturing Practices (cGMP), United States Pharmacopeia (USP), FDA regulations, and Mikart Standard Operating Procedures (SOPs).

Responsibilities

• Receive incoming samples, including water, environmental, raw material, and finished dosage form samples, ensuring all information is accurately and promptly documented in laboratory logs and tracking systems.
• Perform microbiological and other required laboratory testing safely and in accordance with cGMP, USP, FDA, and Mikart specifications, procedures, and test methods.
• Immediately report any discrepancy, suspect, atypical, or out-of-specification (OOS) results to the Microbiology Supervisor and accurately execute investigation plans as directed.
• Generate, review, and revise microbiological test specifications, methods, and procedures as needed.
• Absorb and implement changes to applicable USP chapters and regulatory requirements.
• Ensure proper handling, labeling, storage, and disposition of all samples, including controlled substances, while maintaining chain of custody and sample integrity.
• Process laboratory waste in accordance with established procedures and environmental, health, and safety regulations.
• Participate in equipment installation, qualification, calibration, maintenance, and performance verification activities.
• Absorb and implement procedural updates to SOPs, test methods, and laboratory documentation for microbiology operations and equipment.
• Accurately complete equipment usage logs, maintenance records, calibration documentation, and laboratory notebooks in a timely manner.
• Maintain laboratory cleanliness and organization while ensuring compliance with aseptic techniques and contamination control practices.
• Participate in internal audits, regulatory inspections, laboratory investigations, and continuous improvement initiatives.
• Support special projects and perform other duties as assigned.

Qualifications

• Bachelor's degree in Microbiology, Biology, Biochemistry, or a related life science required.
• Minimum of 1–3 years of microbiology laboratory experience in a pharmaceutical, biotechnology, or regulated manufacturing environment preferred.
• Experience working in a cGMP laboratory environment is highly desirable.
• Knowledge of USP microbiological testing requirements, FDA regulations, and aseptic laboratory techniques.
• Experience performing environmental monitoring, water testing, microbial limits testing, sterility testing, and identification of microorganisms is preferred.
• Proficiency with Microsoft Office applications and laboratory documentation systems.