QC Scientist - Microbiology Pharma (80 - 100%)
Core
Lead projects to implement and validate innovative microbiological analytical methods and equipment within a GMP-regulated QC laboratory, while supervising customer projects for utility qualification testing and related analytical services.
Role type
Senior QC Microbiology Scientist (Project Lead & Customer Service)
Builds
Validated microbiological analytical methods, utility testing protocols, and GMP-compliant analytical reports for pharmaceutical clients.
Domain
Life Sciences / Pharmaceutical Quality Control / Microbiology
Required skills
Microbiology method validation, Utility testing (TOC, conductivity, gas testing), GMP compliance, Project management, LIMS configuration, Root cause analysis (OOS), Equipment qualification (DQ/IQ/OQ)
Preferred skills
MALDI-TOF experience, Clean water analysis, Computer system validation, Digitalization affinity
Technologies
LIMS, TOC analyzers, Conductivity meters, Gas testing equipment
Responsibilities
Lead implementation of new analytical methods and equipment, Coordinate with internal QA and external suppliers, Ensure GMP and regulatory guideline compliance, Manage project timelines and resources, Train and mentor laboratory staff, Process laboratory deviations and root cause analyses
Seniority
Senior, hands-on IC with project leadership