QC Microbiology Data Reviewer and Writer

Company: Integrated Resources, Inc
Location: Indianapolis
Posted on: January 22, 2026

Job Description:

Job Description Job Description Job Title: QC Microbiology Data Reviewer and Writer Location: Indianapolis, IN (Hybrid/Onsite: Onsite) Duration- 12 months (Possible Extension) Work Schedule: Monday - Friday, Business Hours (Weekends and Holidays as needed) 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 sczr2

Keywords: Integrated Resources, Inc, Kokomo , QC Microbiology Data Reviewer and Writer, IT / Software / Systems , Indianapolis, Indiana