Microbiology Laboratory Data Reviewer

Job Title: QC Microbiology Data Reviewer and Writer
Hybrid/Onsite: Onsite 5x a week

Site Location: Indianapolis, IN
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

Job Types: Full-time, Contract

Pay: $55.00 per hour

Benefits:

• 401(k)

Work Location: In person

Salary : $55