Microbiology Senior Analyst

GMP Compliance & Testing:

• Adhere to current Good Manufacturing Practices (cGMP) in all activities.
• Perform microbial limit tests for finished products, raw materials, compressed air, surfaces, and air in production areas and sampling rooms.
• Conduct Personal Hygiene tests for employees and microbial testing for water systems.
• Instrument Monitoring & Calibration:
• Monitor the temperature and performance of lab instruments, including calibration as per SOPs.
• Perform media preparation, sterilization, and quality control of lab instruments.

Sample Testing & Documentation:

• Analyze samples using approved methods, maintain traceability by recording all activities in logbooks, and report test results in a timely manner using approved forms.
• Investigate and document OOS (Out of Specification) results and participate in CAPA processes.
• Housekeeping & Waste Management:
• Ensure neatness in the lab, manage waste disposal according to SOPs, and perform decontamination of biohazardous waste.
• Additional Responsibilities:
• Assist in preparing and reviewing SOPs, specifications, protocols, and trending reports.
• Participate in environmental monitoring, EMPQ, and risk assessment studies.
• Follow up on instrument calibration programs and ensure compliance with Good Laboratory Practices.