What are the responsibilities and job description for the QC Microbiology Data Reviewer and Writer position at TSR Consulting?
**Please only local candidates to Indianapolis IN
84025
TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.
Our client, a leading pharmaceutical company is hiring a QC Microbiology Data Reviewer and Writer for a 12 months contracting assignment.
Must have skills:
- Minimum 4 years’ experience in GMP microbiology laboratory data review
- Experience with CAPA and deviations
- 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
- Bachelor’s degree in microbiology , Biology or Biotechnology or equivalent
- Preferred training in Quality systems, cGMP, and Data Integrity
Pay: $55-56/hour W2
Location: Indianapolis, IN
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
Salary : $55 - $56