TSR Consulting is hiring: QC Microbiology Data Reviewer and Writer in Indianapol

Job Title: QC Microbiology Data Reviewer and Writer

Hybrid/Onsite: Onsite

Site Location: Indianapolis, IN

Job Type: Contract, W2

Work Schedule: Monday - Friday, Business Hours (Weekends and Holidays as needed)

Duration: 12 months+

Job ID: 84025

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 SOPs, 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 SOPs

• 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:

• Bachelors degree in microbiology , Biology or Biotechnology or equivalent

• Preferred training in Quality systems, cGMP, and Data Integrity