QC Analyst I, QC - Micro & EM(2nd Shift)
Core
Supporting contributor to the Environmental Monitoring (EM) program ensuring compliance with GMP standards in aseptic manufacturing environments.
Role type
QC Analyst I (Microbiology & Environmental Monitoring)
Builds
Aseptic manufacturing environment compliance and sterile product safety
Domain
Biologics / Gene Therapy / Pharmaceutical Manufacturing
Deliverable
physical/clinical work
Required skills
GMP principles, aseptic sampling, microbial testing (Gram-stain, Endotoxin, Bioburden), data trending (JMP, LIMS), root cause analysis, sterile gowning
Preferred skills
Aseptic techniques, GMP environment experience, environmental monitoring activities, microbial testing experience
Technologies
JMP, LIMS
Responsibilities
Perform EM sampling (air, surface, personnel) inside sterile manufacturing areas; Conduct microbial testing including Gram-stain, Growth promotion, Endotoxin, Bioburden, Osmolality, pH; Support trending of EM data using software; Support investigations to determine root cause of OOS; Train junior staff in laboratory skills and scheduling EM sampling; Participate in Media Fill/Aseptic Process Simulations (APS) qualifications
Seniority
Entry-level to Junior, hands-on IC
