Marin Metro Area, CA
Tuesday-Saturday Day or Sunday- Thursday Shift
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, the incumbent will be primarily responsible for performing environmental monitoring sampling and testing of the facilities, equipment, and utilities under cGMP guidelines. In addition, they will be responsible for performing biochemical and microbiological assays of samples under cGMP and GLP guidelines. Work assignments will encompass activities from routine to semi-routine in nature with the ability to recognize deviations from accepted limits and practices. The incumbent will be responsible for completing assignments in a timely manner, for assisting with troubleshooting, assisting with data trending, and for follow-up on any testing issues or excursions. Good record keeping, organizational, written and verbal communication skills are essential. Functional activities could include supporting process validation studies, contributing to investigations, method validations, assay method/procedure development, reagent preparation, in-process microbiological and analytical testing, growth promotion of media, and microbiological identification testing. The position requires knowledge of, but is not limited to, aseptic technique, microbial challenge studies, bioburden determination, microbiological method validation, endotoxin, protein, activity, TOC, and other similar analysis methods. The incumbent 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.
Demonstrated working knowledge related to specific functional activities.
Ability to perform most tasks with supervision.
Computer literacy is required.
Experience with Microsoft Word and Excel required; experience with Access and PowerPoint a plus.
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 or Associates of Science with at least 4 years of relevant laboratory experience.