QC Microbiologist

Job Responsibilities:

• Perform routine and non-routine microbiological testing of pharmaceutical products, water systems, and environmental monitoring samples according to GMP and company SOPs.
• Conduct endotoxin testing for raw materials, bulk products, and final drug formulations.
• Carry out bioburden testing to assess the microbial load in drug substances, water samples, and production components.
• Execute sterility testing using direct inoculation or membrane filtration methods
• Support the Sterility Assurance Program through risk-based contamination control strategies, cleanroom monitoring, and aseptic process simulations (media fills).
• Perform microbial identification using classical and rapid microbiological methods.
• Ensure strict adherence to cGMP, aseptic techniques, and data integrity requirements.
• Document all work accurately and in compliance with laboratory standards and regulatory expectations.
• Investigate out-of-specification (OOS) results and support root cause analysis and CAPA development.
• Participate in environmental and utility monitoring programs for manufacturing clean rooms, including air, surface, and personnel monitoring.
• Assist in validation of microbiological test methods and qualification of laboratory equipment.
• Contribute to audits, inspections, and continuous improvement initiatives within the QC Microbiology laboratory.

Qualifications:

• Bachelor’s or Master’s degree in Microbiology, Biology, or a related field.
• Minimum of 2-3 years of experience in a microbiology laboratory, preferably within the pharmaceutical or biotech industry.
• Strong knowledge of GMP, FDA, and other regulatory guidelines for pharmaceutical manufacturing.
• Hands-on experience with microbiological testing techniques, including sterility, endotoxin, and microbial identification.
• Familiarity with aseptic techniques and cleanroom environments.
• Proficient in the use of microbiological laboratory equipment (e.g., autoclaves, incubators, laminar flow hoods).