Quality Control, Microbiology
Marin Metro Area, CA
The Quality Control Microbiology, Environmental Monitoring, Analyst I under direct supervision, is responsible for performing microbiological, biochemical, and chemical evaluations of the manufacturing facilities, utilities, and equipment. With experience they would perform as a back-up for QC In-process and QC Microbial ID testing.
Under direct supervision:
- Primarily responsible for performing environmental monitoring sampling and testing of the facilities, equipment, and utilities under cGMP guidelines.
- Performing biochemical and microbiological assays of samples under cGMP and GLP guidelines.
- Good record keeping, organizational, written and verbal communication skills are essential.
- Functional activities could include:
- Reagent preparation
- In-process microbiological and analytical testing
- Growth promotion of media
- Microbiological identification testing.
- Requires knowledge of, but is not limited to:
- Aseptic technique
- Microbial challenge studies
- Bioburden determination
- Microbiological method validation
- Protein activity
- Other similar analysis methods.
- Must be willing to work second shift, overtime, weekends, and holidays as required.
- QC cGMP experience beneficial.
- Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices.
- Must have excellent record keeping, written and verbal skills.
- Experienced with microbiological methodologies and a variety of analytical instrumentation; capable of troubleshooting assays. Efficient in scheduling and facilitating the execution of routine and non-routine testing.
- Bachelor of Science or Bachelor of Arts in a Biological or Biochemical Science with at least 0-2 years of relevant laboratory experience