QC Microbiology Specialist I
Core
Perform non-routine complex testing, lead qualification and study-directed activities, and support investigations of OOS assays in a cGMP laboratory environment.
Role type
Senior IC QC Microbiology Specialist
Builds
Laboratory testing results and compliance documentation for biopharma clients
Domain
Biopharma / Quality Control
Required skills
cGMP compliance, complex testing execution, change control process management, OOS investigation support, LEAN and Six Sigma principles, audit readiness, technical training, high-throughput workflow management
Preferred skills
AS or BS degree in Microbiology, experience in cGMP environments
Technologies
Laboratory information management systems (LIMS), analytical instrumentation
Responsibilities
Perform non-routine complex testing and execute change control actions; Lead qualification and study-directed testing activities; Support intermediate investigations of OOS assays and events; Act as a qualified trainer and Subject Matter Expert for multiple tests; Apply LEAN lab and Six Sigma principles to laboratory processes; Ensure compliance with cGMP and participate in audits and inspections
Seniority
Mid-Senior, hands-on IC