Careers Integrated Resources Inc
QC Microbiology Data Reviewer and Writer
Careers Integrated Resources Inc, Indianapolis, Indiana, United States
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 · 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
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 · 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