Microbiology Quality Specialist - Indianapolis - Integrated Resources, Inc ( IRI )

    Integrated Resources, Inc ( IRI )
    Integrated Resources, Inc ( IRI ) Indianapolis

    4 days ago

    Pharmaceutical / Bio-tech
    Description

    Key Responsibilities


    • Perform independent and thorough review of QC microbiology data for completeness, accuracy, and cGMP compliance


    • Verify raw data, calculations, instrument outputs, electronic records for assays including but not limited to bioburden, sterility, endotoxin, media qualification, and environmental monitoring


    • Confirm adherence to SOP's, test methods, and approved protocols


    • Ensure documentation meets ALCOA+ data integrity principles


    • Identify discrepancies, errors or atypical results and work with analysts to resolve issues and ensure right the first-time documentation


    • Review EM results and ensure proper escalation of out of trend or excursions findings


    • Write deviations, CAPAs and revise SOP's


    • Write monthly / quarterly reports for environmental monitoring


    • Support internal and external audits by providing clear, complaint documentation

    Qualifications


    • Minimum 4 years' experience in GMP microbiology laboratory data review


    • Knowledge of Bioburden, Endotoxin, Sterility, Media qualification, and Environmental Monitoring


    • Experience in writing and supporting investigations, deviations, or CAPA processes and SOPs.


    • Experience with Sherpa or other LIMS


    • Intermediate level MS SharePoint experience


    • SAP experience preferred

    Education:


    • Bachelor's degree in microbiology , Biology or Biotechnology or equivalent


    • Preferred training in Quality systems, cGMP, and Data Integrity


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