Job description:
The QC Microbiologist ensures the microbiological quality, safety, and compliance of raw materials, in-process samples, finished products, and the manufacturing environment. This role is critical in maintaining Positive Manufacturing Practices (GMP) and regulatory standards, preventing contamination, and supporting continuous improvement in quality systems.
Key Responsibilities
1. Microbiological Testing
Perform microbial limit tests, bioburden, endotoxin, and sterility testing on raw materials, intermediates, and finished products.
Conduct water analysis (purified water, WFI, potable water) for microbial contamination.
Execute environmental monitoring of cleanrooms, controlled areas, and personnel.
Carry out microbial identification using conventional and rapid methods (e.g., Gram staining, PCR, MALDI-TOF).
2. Documentation & Compliance
Maintain accurate laboratory records in compliance with GMP, GLP, and ISO standards.
Prepare and review SOPs, test protocols, and validation reports.
Ensure compliance with regulatory guidelines (FDA, EMA, WHO, ICH).




Support internal and external audits by providing microbiological data and documentation.
3. Quality Assurance Support
Investigate microbiological deviations, out-of-specification (OOS) results, and contamination events.
Participate in root cause analysis and implement corrective and preventive actions (CAPA).
Collaborate with QA to ensure product release decisions are based on valid microbiological data
4. Method Development & Validation
Develop, validate, and optimize microbiological test methods.
Perform media preparation and growth promotion testing.
Support qualification and calibration of laboratory equipment (incubators, autoclaves, biosafety cabinets, particle counters).
5. Training & Collaboration
Train production and QC staff on aseptic techniques and microbiological awareness.
Work closely with manufacturing, QA, and R&D; teams to ensure microbiological quality standards are met.
Provide technical

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