senior analyst

Job Description Summary

The Microbiologist is responsible for performing microbiological testing of raw materials, finished products, stability, swab, water, and environmental monitoring samples in accordance with approved specifications, test methods, and regulatory requirements.

The role ensures compliance with Good Laboratory Practices (GLP), data integrity requirements, environmental management systems (EMS), and audit readiness while supporting quality assurance through accurate testing, trending, documentation, calibration, and validation activities.

Job Description

• Perform sampling and microbiological analysis of raw materials, finished products, stability samples, swab samples, and other assigned test samples as per approved specifications and test methods.
• Conduct sampling and microbiological analysis of water samples according to approved schedules and test procedures.
• Carry out Environmental Monitoring (EM) activities in manufacturing and microbiology areas as per approved monitoring programs.
• Review and release test results for water, raw materials, finished products, stability samples, swab samples, and other assigned samples in compliance with quality requirements.
• Review and release Environmental Monitoring results and ensure timely reporting.
• Monitor and record temperature conditions of microbiological instruments, incubators, refrigerators, and other controlled equipment.
• Request Reports of Analysis (ROA) and Testing Instruction (TI) sheets required for testing, reporting, and product release activities.
• Prepare, maintain, and review Environmental Monitoring and Water Trend reports to identify potential quality concerns and ensure continued process control.
• Review laboratory logbooks, worksheets, records, and associated documentation for completeness, accuracy, and compliance. Coordinate and ensure timely calibration, qualification, and maintenance of laboratory equipment and instruments.
• Handle microbiological media, cultures, reference strains, and related laboratory materials in accordance with approved procedures.
• Perform microbial method validation, verification, and method transfer activities as required.
• Adhere to Good Laboratory Practices (GLP), data integrity requirements, and real-time online documentation practices.
• Maintain continuous audit readiness and support internal, customer, and regulatory inspections.
• Maintain high standards of workplace housekeeping through effective implementation of 5S practices, teamwork, and self-discipline. Identify and report environmental aspects and impacts related to workplace activities and contribute to the Environmental Management System (EMS).