Analyst, QC (Environmental Monitoring)
Core
Perform environmental monitoring and microbiological testing to ensure cleanroom and manufacturing areas meet GMP quality and safety standards for medicine production.
Role type
QC Analyst (Environmental Monitoring)
Builds
GMP-compliant medicines
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
Microbiological testing, Environmental monitoring sampling, GMP compliance, Data integrity, Root cause analysis, Laboratory operations management, Sample logistics, Regulatory knowledge (FDA/EMEA/ICH)
Responsibilities
Perform microbiological testing (bioburden, LAL, plating/counting, microbial identification, EM sampling, particulate monitoring). Conduct environmental monitoring (air, surface, viable, and non-viable sampling) across manufacturing and cleanroom areas. Analyze raw materials, in-process, environmental, and final product samples per SOPs and GMP requirements. Document, review, and report results in compliance with cGMP and data integrity standards. Support trending, investigation, and deviation/OOS activities, including root cause analysis. Maintain laboratory operations (equipment upkeep, housekeeping, reagents, consumables, and inventory control). Manage sample logistics including retention samples, external testing coordination, and QC documentation/shipping. Prepare and maintain GMP-compliant standards and reagents. Ensure timely testing and reporting to meet operational and production needs. Participate in peer review and continuous improvement initiatives.
