Specialist, QC Microbiology
Core
Perform routine microbiological testing of in-process, final product, and stability samples, along with environmental and facility monitoring in a GMP-compliant laboratory.
Role type
Specialist, QC Microbiology (Laboratory Analyst)
Builds
In-process and final product quality data for cell therapy manufacturing
Domain
Life Sciences / Cell Therapy / Microbiology
Required skills
Microbiological testing techniques, GMP compliance, Data verification, Laboratory safety protocols, Technical documentation, Problem-solving
Preferred skills
LIMS/ELN systems, Method transfer/verification, CAPA/Deviation management, Technical writing
Technologies
LIMS, ELN, Biosafety Level 2 (BSL-2) equipment
Responsibilities
Perform routine testing of in-process, final product and stability samples; Perform environmental/facilities monitoring and microbiological testing; Perform data verification, data review and review of GMP documentation; Perform document revision, project, CAPA and deviation/investigation related tasks; Train analysts on general job duties
Seniority
Specialist, hands-on IC