Responsible for execution of microbiology laboratory related activities such as: sampling and testing related to the Microbial Environmental Monitoring (EM) Program, microbiological testing of raw materials, finished products, utilities and water systems. Leads the conduct of GMP quality event investigations in the lab or manufacturing area; peer review of laboratory raw data; micro data trending, reporting adverse trends and identification of corrective actions; conducts micro method development and validation. These activities are performed following company GMP procedures and all applicable regulatory and safety requirements.
* Bachelor’s degree in Microbiology or equivalent. Advanced degree desirable.
* Microbiology degree- desirable 3+ years of quality control microbiology laboratory experience in a pharmaceutical or biotech environment.
* Equivalent degree- desirable 5+ years of microbiology laboratory experience in a pharmaceutical or biotech environment
* Expertise in micro testing of cleaning validation and cleaning monitoring samples
* Expertise in organisms identification
* Expertise in Investigations writing
* Knowledge and understanding of cGMP regulations and good documentation and laboratory practices
Proficiency with Microsoft Suite (Word, PowerPoint, and Excel)
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