Job Summary:
The Quality Control Microbiology Technician is responsible for performing routine microbiological testing and monitoring to support the manufacturing of pharmaceutical or biopharmaceutical products. The role focuses on environmental monitoring, cleanroom sampling, bioburden and endotoxin testing, and supporting investigations related to microbiological quality.
Key Responsibilities:
- Perform environmental monitoring (EM) of controlled cleanroom environments (viable air, non-viable particles, surface sampling, personnel monitoring).
- Conduct bioburden testing on in-process materials, water samples, and raw materials in compliance with cGMP requirements.
- Execute endotoxin testing (LAL assay) on pharmaceutical products, equipment rinse waters, and final product samples.
- Collect and process microbiological samples from manufacturing, utilities (eg, purified water, WFI, compressed gas), and laboratory environments.
- Document all activities in accordance with Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP).
- Ensure compliance with all applicable SOPs, regulatory standards (eg, USP, EP), and internal quality policies.
Qualifications:
- Bachelor's degree in Microbiology, Biology, or related life science discipline.
- 1+ years in a GMP-regulated pharmaceutical or biopharmaceutical QC Microbiology laboratory.
- Hands-on experience with sampling, environmental monitoring, bioburden testing, and endotoxin testing is required.
- Knowledge of aseptic techniques and cleanroom behavior standards.
- Proficiency in Microsoft Office applications.
- Strong communication and team collaboration skills.