Job Description

The Data Reviewer – Quality Control Microbiology is responsible for the detailed review of microbiological data to ensure accuracy, compliance, and alignment with regulatory requirements. This role supports the quality organization by verifying the integrity of test results, conducting investigations as needed, and ensuring timely documentation of findings. The position emphasizes data integrity, documentation accuracy, and collaboration with laboratory teams to support the production and release of high-quality products.

Responsibilities

• 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.
• Performs other activities as needed.

Minimum Requirements:

• 1-2 years working in a GxP laboratory environment.
• 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.

Preferred:

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

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