Sr Associate I, Quality Control Microbiology
Core
Lead operational aspects of QC Microbiology laboratory, performing and training others on microbial testing of in-process drug substance, raw materials, and environmental monitoring.
Role type
Senior IC QC Microbiology Associate
Builds
In-process drug substance, raw materials, and environmental monitoring data for pharmaceutical manufacturing
Domain
Pharmaceutical manufacturing / Microbiology
Required skills
Microbiology testing, aseptic techniques, LIMS, GMP compliance, data integrity, statistical analysis, document control, environmental monitoring, utility sampling
Preferred skills
Utilities monitoring, training experience, Veeva/Kneat proficiency, GMP/GLP/GDP knowledge, compendial test methods, microbial ID systems, LEAN lab, Six Sigma
Technologies
LIMS, Veeva, Kneat, Microsoft Word, Microsoft Excel, MALDI, MicroSeq
Responsibilities
Perform microbiology testing (bioburden, endotoxin, plate reading, identification), conduct routine environmental monitoring, collect and process utility samples, review test data in LIMS, prepare quarterly EM/UM reports, troubleshoot complex assays, perform investigations, maintain laboratory cleanliness and equipment readiness
Seniority
Senior, hands-on IC