Job Description

• Responsible for the detailed review of microbiological data to ensure accuracy, compliance, and alignment with regulatory requirements.
• Supports the quality organization by verifying the integrity of test results, conducting investigations as needed, and ensuring timely documentation of findings.
• Emphasizes data integrity, documentation accuracy, and collaboration with laboratory teams to support the production and release of high-quality products
• Perform detailed reviews of microbiological data, including routine and non-routine analyses of raw materials, in-process solutions, finished products, antimicrobial effectiveness testing, microbial growth promotion, environmental monitoring, cleaning surveillance, media qualification and microbial identification.
• Responsible for conducting reagent review.
• Conduct Phase I laboratory investigations. 

• 1-2 years working in a GxP laboratory environment.
• BS Degree in Microbiology or Life Sciences 
• Proficient in Microsoft Office applications. Strong written and oral communication skills (English).
• Experience working in current Good Manufacturing Practice (cGMP) or other cGxP environments.
• Experience performing microbiology data review.

• Experience using Laboratory Information Management System (LIMS).
• Experience with technical writing in a regulated environment.
• Top skills - Technical skills (some microbiology knowledge, data review knowledge, regulatory knowledge,), Attention to detail, problem solving and good at communication.
• Experience with reviewing microbiology method results - environmental monitoring, cleanings surveillance, media qualification, water filtration and potential product release (raw materials, bulks, finished good) executing phase I investigations

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