QC Biologist

Quality Control Microbiologist

We are seeking a detail-oriented Quality Control Microbiologist to support quality control operations in a regulated biotechnology or pharmaceutical environment.

About the Position

• The ideal candidate will be responsible for performing microbiological testing, environmental monitoring, and utilities sampling to ensure compliance with industry standards and regulatory requirements.

Responsibilities

1. Conduct sampling of Water for Injection, Purified Water, Clean Steam, and Process Gases.
2. Perform environmental monitoring of cleanroom suites and laboratory areas.
3. Support QC operations such as instrument qualification, SOP updates, and record keeping.
4. Manage laboratory reagent and supply inventory.
5. Conduct laboratory investigations (OOS, Out of Trend, deviations, invalid assays) and implement CAPAs.
6. Participate in facility qualification, method transfer, and method validation activities.
7. Adhere to gowning requirements for cleanroom access and perform tasks requiring extended periods of standing and movement.

Requirements

• Bachelor's degree or higher in Microbiology, Biology, Biotechnology, or a related scientific field.
• Minimum 2 years of experience in an FDA-regulated biotech or pharmaceutical company (5 years preferred without higher education).
• Proficiency in microbiological testing methods, including PCR, endotoxin, sterility, and bioburden testing.
• Familiarity with USP/EP, cGMP, and EU GMP regulations.
• Experience with equipment validation and environmental monitoring.
• Strong analytical, problem-solving, and communication skills.
• Ability to work in a fast-paced, highly regulated environment with attention to detail.

Preferred Skills

• Experience in method validation and method transfer.
• Knowledge of inventory management for laboratory supplies.
• Hands-on experience with FDA regulatory compliance.