QC Environmental Monitoring Analyst II
Core
Perform routine environmental monitoring, utility sampling, and analysis in classified clean rooms and water/steam systems for biopharma manufacturing.
Role type
Mid-level IC QC Environmental Monitoring Analyst
Builds
Clean room and utility system compliance data for biopharma clients
Domain
Biopharma / cGMP Manufacturing
Deliverable
physical/clinical work
Required skills
Environmental monitoring, utility sampling (WFI, RO/DI, steam, compressed air), gowning in ISO-5 to ISO-8 environments, media fill visual inspection, SOP execution, lab maintenance, peer review, staff training
Preferred skills
AS or BS in Microbiology, process improvement, independent troubleshooting
Technologies
Lab equipment, software for data recording
Responsibilities
Perform routine environmental monitoring of classified clean rooms; Perform routine utility sampling and analysis of Water for Injection, RO/DI, USP Purified water, and Clean Steam systems; Monitor classified clean rooms during manufacturing operations; Execute protocols, experiments, and SOPs; Review work of peers and SOP document changes; Assist in preparation of investigations and reports; Conduct visual inspection of media fill vials and plates; Train staff in routine processes
Seniority
Mid-level, hands-on IC