Job Description

QC Microbioloist
Location: CT
Duration: 7 months

Key Responsibilities:

• Perform routine microbiological testing of raw materials, in-process samples, and finished products, including bioburden, endotoxin, sterility, and microbial limits tests.
• Conduct environmental monitoring of cleanrooms, utilities (e.g., purified water, WFI, compressed air), and manufacturing areas.
• Perform microbial identification using conventional and rapid methods (e.g., Gram staining, MALDI-TOF, PCR).
• Execute growth promotion, media fill, and disinfectant efficacy testing as required.
• Maintain laboratory equipment, media inventories, and calibration/maintenance logs.
• Review and record test results accurately and in compliance with data integrity and cGMP standards.
• Participate in deviation, OOS (Out of Specification), and CAPA investigations related to microbiological testing.
• Support validation and qualification activities (e.g., cleanroom qualification, autoclave validation, and environmental monitoring system validation).
• Contribute to continuous improvement of QC microbiology procedures, methods, and documentation.

Qualifications:

• Bachelor's degree in Microbiology, Biology, or a related Life Science field.
• 5-6 years of experience in a GMP microbiology or QC laboratory (pharmaceutical, biotechnology, or medical device industry).
• Knowledge of USP, EP, and FDA guidelines for microbiological testing and environmental monitoring.
• Familiarity with aseptic techniques and contamination control in cleanroom environments.
• Experience with LIMS, Empower, or other electronic laboratory data systems is an advantage.
• Understanding of data integrity (ALCOA+) and cGMP principles.

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