Environmental Monitoring
Core
Collect environmental monitoring, cleaning validation, and ICP testing samples aseptically in a biologics facility and perform QC testing to ensure GMP compliance.
Role type
Environmental Monitoring Scientist (QC)
Builds
Biologics production environment quality control data
Domain
Life sciences / Biologics manufacturing
Required skills
Aseptic technique, Microbiology, GMP compliance, LIMS, Empower software, Bioburden testing, Endotoxin testing, Total Organic Carbon testing, Conductivity testing, Sample management
Preferred skills
Lean lab operations, 6S laboratory layout, Continuous improvement programs
Technologies
LIMS, Empower software
Responsibilities
Aseptically collect environmental monitoring, cleaning validation, and ICP testing samples; Perform QC testing including Bioburden, Endotoxin, Total Organic Carbon, Concentration, and Conductivity; Maintain sample chain of custody and manage sample aliquoting, storage, receipt, and shipping; Review manufacturing schedules for dynamic environmental monitoring; Reconcile environmental monitoring samples at the end of production runs; Perform laboratory and equipment maintenance; Participate in lean lab operation and continuous improvement programs.
Seniority
Entry-level to Mid-level, hands-on IC