What are the responsibilities and job description for the QC Microbiology Data Reviewer position at Integrated Resources, Inc ( IRI )?
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
Salary : $56