Microbiologist

Berkeley, CA

$30/HR

The Microbiologist will perform standard microbiology assays and validation activities to support GMP and clinical and developmental product release.

• Microbiologist Responsibilities: Capable of conducting microbiological method validation including bioburden, sterility, LAL (endotoxin), and virology methods supporting biopharmaceutical, clinical, and development products.
• Execute microbiological methods per approved protocols and testing of routine and investigational samples.
• Familiarity with all microbiological compendial methods for specific commercial products. Maintains records of method qualification/validation and other microbiological-related methods.
• Investigate questionable test results, write protocol deviation report (PDR), and investigate/test plans when applicable. Collaborates effectively with Quality Assurance validation on the method validation approach.
• Keeps current with revisions to compendial monographs and to compendial test methods used in the microbiology division. Write protocols, and revise SOPs affected by these compendial changes and changes arising as a function of a CAPA, per approved Change Control.
• Thorough knowledge of microbiological analytical methods, and compendial requirements (USP, EP, JP). Knowledge of biologics and manufacturing processes.

• Microbiologist Requirements: Education requirements- Bachelor's degree in microbiology or related degree or technical field
• Minimum Experience: 2 years of experience in microbiological method validation in pharmaceutical or related industry or an equivalent combination of education and experience.
• Strong computer skills (Word, Excel, Access, PowerPoint, LIMS, SAP).