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Job Requirements of QC Microbiology Data Reviewer and Writer:
-
Employment Type:
Contractor
-
Location:
Indianapolis, IN (Onsite)
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QC Microbiology Data Reviewer and Writer
Careers Integrated Resources Inc
Indianapolis, IN (Onsite)
Contractor
Job Title: QC Microbiology Data Reviewer and Writer
Job Location: Indianapolis, IN
Duration: 12 Months
Work Schedule: Monday - Friday, Business Hours (Weekends and Holidays as needed)
Key Responsibilities
Qualifications
Education:
Job Location: Indianapolis, IN
Duration: 12 Months
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,
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