Specialist, QC Microbiology
Core
Perform sterility, bacterial endotoxin, bioburden, and growth promotion testing on drug products, substances, and raw materials in a cGMP-compliant laboratory.
Role type
QC Microbiology Analyst
Builds
Drug product and substance quality data for patient safety
Domain
Pharmaceutical manufacturing / Microbiology
Required skills
Sterility testing, Bacterial Endotoxin Testing, Bioburden testing, Growth Promotion testing, Microorganism identification, PCR testing, cGMP compliance, Laboratory documentation, SOP adherence
Preferred skills
Aseptic manufacturing experience, Sterility testing experience
Technologies
PCR, cGMP procedures
Responsibilities
Perform sterility testing on Drug Product samples; Perform Bacterial Endotoxin Testing on Drug Product, Drug Substance, Raw Material and Utility samples; Perform Bioburden testing on Drug Substance, Raw Materials and Utility samples; Carry out identifications of Microorganisms isolated post testing activities; Carry out the Minute Mouse Virus by PCR for in-process samples; Completing all laboratory documentation in a timely and accurate manner; Ensuring a high standard of housekeeping and safety is maintained in the laboratory
Seniority
Entry-level to Junior, hands-on IC