QC Microbiology Data Reviewer and Writer Job at Careers Integrated Resources Inc

Job Title: QC Microbiology Data Reviewer and Writer

Job Location: Indianapolis, IN

Duration: 12 Months+ (Possibilities of 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 xrczosw

· 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