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Microbiology Quality Investigator

Nephron Pharmaceuticals · West Columbia, South Carolina, US

Description Job Purpose: (Summarize the job in a few sentences) Microbiology Quality Investigators ensure compliance with FDA regulations in the areas of mic...

Job description

Description Job Purpose: (Summarize the job in a few sentences) Microbiology Quality Investigators ensure compliance with FDA regulations in the areas of microbiology-related investigations. Microbiology Quality Investigators are responsible for ensuring the Microbiology department’s adherence to FDA regulations. This involves completion of non-conformance investigations, the drafting of pertinent memorandums, managing deviations, and implementing robust corrective and preventive actions (CAPAs). A key aspect of the role is effective inter-departmental collaboration to facilitate the timely completion of all projects. Furthermore, investigators must skillfully manage their individual workload and adapt to shifting priorities to meet departmental and company demands. Essential Duties and Responsibilities:(list clear and concise job duties specific to the role) - Effectively completes microbiology excursion reports and associated documentation per procedure within specified timelines. - Executes timely completion of CAPAs, Quality Events (QE), memorandums, and deviations as they pertain to the Microbiology program. - Coordinates with all areas of Microbiology and other departments to...