Quality Control Analyst
Core
Coordinates laboratory testing, product disposition, method validations, and prepares reports for microbiology investigations in a GMP-regulated environment.
Role type
Senior IC Quality Control Analyst (Microbiology)
Builds
Laboratory testing release records, validation reports, and investigation findings for pharmaceutical/medical device products.
Domain
Pharmaceutical/Medical Device Manufacturing, Microbiology, GMP
Required skills
Microbiology, GMP regulations, Global TrackWise system, Lab procedures, Corrective action implementation, SAP, LIMS, Bioburden testing, Sterility testing, Environmental monitoring, Trend analysis, Budget management
Preferred skills
Industrial Microbiology, Pharmaceutical/Medical Device industry experience, Water systems knowledge, Clean room operations, Aseptic filling, Process validation, Audit experience, Microsoft Office
Technologies
Global TrackWise, SAP, LIMS, Microsoft Office
Responsibilities
Perform and coordinate microbiology lab investigations and method validations; Interpret results of bioburden, microbial limits, and sterility testing; Investigate out-of-limit conditions and implement corrective actions; Review and approve laboratory testing documentation; Lead others indirectly; Prepare trend and metric laboratory reports; Manage laboratory supplies and inventory within budget; Review regulatory and technical journals for guidance.
Seniority
Mid-Senior, hands-on IC with indirect leadership