QC Microbiologist

Role Overview

We are seeking a Microbiologist to execute and oversee microbiological testing for a sterile injectable pharmaceutical facility. You will ensure full compliance with cGMP, pharmacopoeial standards, and company SOPs, directly supporting routine testing, water/utility monitoring, and retain sample management.

Key Responsibilities

• Core Testing & Analysis: Perform Bacterial Endotoxin Testing (BET), Sterility Testing, and Microbial Limit Testing (MLT) using validated aseptic methods.
• Water & Utility Monitoring: Conduct routine testing of Water for Injection (WFI), Purified Water, and process utility samples.
• Stability & Retains: Execute stability study testing per schedules and manage the retain sample lifecycle (receipt, inventory, storage, and reconciliation).
• Media & Culture Control: Prepare and maintain microbiology media, test reagents, and reference cultures, ensuring growth promotion and suitability testing are complete.
• Lab Compliance & Equipment: Maintain cleanroom integrity, LAF/BSC workstations, autoclaves, and incubators; support environmental/viable monitoring.
• Documentation & Data Integrity: Maintain test records, logbooks, and worksheets in line with Good Documentation Practices (GDP) and ALCOA+ principles.
• Deviations & Investigations: Escalates invalid, OOS/OOT, or atypical results immediately and assist with root-cause investigations.