Specialist, QC Microbiology
Core
Perform sterility, bacterial endotoxin, bioburden, and growth promotion testing on drug products, substances, and raw materials in a cGMP-compliant microbiology laboratory.
Role type
QC Microbiology Analyst
Builds
Drug products, drug substances, and raw materials for pharmaceutical manufacturing
Domain
Pharmaceutical manufacturing / Biologics
Required skills
Microbiology, aseptic manufacturing, sterility testing, bacterial endotoxin testing, bioburden testing, growth promotion testing, PCR, cGMP compliance, laboratory documentation, SOP adherence
Preferred skills
Sterility experience, media lot identification, minute mouse virus testing
Technologies
PCR
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; Perform Growth Promotion testing of media lots; Carry out identifications of Microorganisms isolated post testing; Perform compendial verification, method transfer/validation, and routine testing; Complete all laboratory documentation; Ensure high standard of housekeeping and safety; Investigate alert/action limit excursions; Assist in authoring and reviewing documentation including SOPs.
Seniority
Junior, hands-on IC