Microbiologist
747 Grayson Street Berkeley California USA 94710 Berkeley, CA 94710 US
Job Description
DESCRIPTION:
Quality Control Microbiology – Perform microbiology (LAL (Endotoxin), bioburden assay and validation activities supporting GMP, Clinical, development product release.
POSITION DUTIES & RESPONSIBILITIES
1. Capable of conducting microbiological method validation including bioburden and (endotoxin) methods supporting biopharmaceutical, clinical and development products.
2. Conduct execution of microbiological methods per approved protocols and testing of routine and investigational samples.
3. Familiarities with all microbiological compendial methods for specific commercial products. Maintains records of method qualification/validation and other microbiological related methods.
4. Keeps current with revisions to compendial monographs and to compendial test methods used in the microbiology division.
6. Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments.
7. Thorough knowledge of microbiological analytical methods, compendial requirements (USP, EP, JP). Knowledge of biologics and manufacturing processes.
8. Strong computer skills (Word, Excel, Access, PowerPoint, LIMS, SAP).
9. Prior experience in a QC microbiology testing laboratory.
10. Ability to work independently with minimum supervision.
REQUIREMENTS:
• Minimum Education bachelor’s degree in microbiology or related science 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.
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