QC Microbiology Data Reviewer and Writer

**Please only local candidates to Indianapolis IN 84025 TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence. Our client, a leading pharmaceutical company is hiring a QC Microbiology Data Reviewer and Writer for a 12+ months contracting assignment. Must have skills: Minimum 4 years’ experience in GMP microbiology laboratory data review Experience with CAPA and deviations 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 SAP experience preferred Bachelor’s degree in microbiology , Biology or Biotechnology or equivalent Preferred training in Quality systems, cGMP, and Data Integrity Pay: $55-56/hour W2 Location: Indianapolis, IN 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

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