Scientist II, Quality Control - Microbiology
Core
Perform microbiological testing of raw materials, in-process materials, finished products, stability, and validation samples in a cGMP laboratory to ensure product quality and compliance.
Role type
Senior IC quality control microbiologist
Builds
Nonsterile pharmaceutical products, dietary supplements, and medical devices
Domain
Pharmaceutical manufacturing / Microbiology
Required skills
Microbial enumeration, environmental monitoring, aseptic techniques, laboratory investigations, SOP writing, data integrity, statistical trending, media preparation, organism isolation
Preferred skills
USP <61> and <62> preparatory testing, nonsterile product testing expertise
Technologies
LIMS, approved statistical software
Responsibilities
Perform microbiological testing of raw materials, in-process materials, finished products, stability, and validation samples; Conduct environmental monitoring and statistical trending of EM data; Initiate, conduct, and write laboratory investigations for microbiological excursions and deviations; Prepare microbiological media, reagents, and test organisms; Interpret, document, and report microbiological results in LIMS; Write and revise SOPs, methods, and technical reports.
Seniority
Senior, hands-on IC