QC Microbiology Data Reviewer and Writer

Indianapolis, IN

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Type: Contract

Experience: 0

Category: Scientific & Clinical

Contractor Work Model: Onsite

Brand: Joulé

Shift: On-Site

Job ID: 344196

Date Posted: 12/15/2025

Shortcut: http://jobs.systemone.com/9rdk5K


Job Title: QC Microbiology Data Reviewer and Writer
Location: Indianapolis, IN
Hours/Schedule: Monday - Friday, Business Hours
Type: Contract
 
Overview
Leading pharmaceutical company looking for an experienced QC Microbiology Data Reviewer. Ideal candidates should have 4 years of experience in GMP Microbiology laboratory data Review. As well as experience writing and supporting investigations, deviations, or CAPA processes. 
 
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
 
Requirements
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


Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. 


 

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