Microbiologist

The Microbiology Analyst is responsible for performing microbiological testing of raw materials, in-process samples, finished products, utilities, and environmental monitoring samples to ensure compliance with GMP, regulatory requirements, and company quality standards.

• Perform microbiological analysis including:
  Bioburden testing

• Microbial limit testing

• Sterility testing

• Endotoxin testing (LAL)

• Environmental monitoring (air, surface, personnel monitoring)

• Water testing (Purified Water, WFI)

• Conduct microbial identification using conventional and automated methods.

• Prepare culture media, reagents, and microbiological solutions.

• Maintain aseptic practices while handling samples.

• Record test results accurately in laboratory notebooks and electronic systems.

• Investigate out-of-specification (OOS), out-of-trend (OOT), and laboratory deviations.

• Participate in method validation, method transfer, and qualification studies.

• Ensure compliance with GMP, GLP, Data Integrity, and regulatory guidelines.

• Operate and maintain microbiology laboratory equipment such as:

• Autoclave

• Incubator

• Colony Counter

• BSC/LAF

• Particle Counter

• Microbial Identification Systems

• Support internal and external audits and regulatory inspections.

• Experience in sterile manufacturing environments preferred.

Skills Required

• Knowledge of GMP, GLP, and aseptic techniques.
• Understanding of USP, EP, IP, and regulatory microbiological requirements.
• Good documentation and analytical skills.
• Ability to investigate microbiological deviations.
• Proficiency in MS Office and laboratory documentation systems.

Preferred Knowledge

• Environmental Monitoring Program (EMP)
• Sterility Assurance
• Water System Monitoring
• Data Integrity Requirements
• FDA, EU GMP, WHO GMP guidelines

Key Performance Indicators (KPIs)

• Timely completion of microbiological testing.
• Compliance with GMP and laboratory procedures.
• Audit readiness.
• Reduction in laboratory errors and deviations.
• Accurate documentation and reporting.

Interested candidates can send resumes to [email protected]

Job Location: Guwahati, Assam