QC Microbiology Data Reviewer and Writer Job at TSR Consulting, Indianapolis, IN

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  • TSR Consulting
  • Indianapolis, IN

Job Description

**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

Job Tags

Local area,

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