QC Microbiology Data Reviewer & GMP Documentation Specialist

SOKOL GxP Services•Indianapolis, IN

10d•$47 - $56

About The Position

QC Microbiology Data Reviewer & GMP Documentation Specialist role supporting GMP microbiology operations through independent review of microbiology data, documentation, and electronic records to ensure accuracy, completeness, and ALCOA+ compliance. The role focuses on review of EM, bioburden, sterility, endotoxin, and media qualification data, along with writing deviations, CAPAs, SOPs, and routine GMP reports. Ideal for an intermediate-level professional (4–7 years) with strong LIMS/GMP experience, working knowledge of SharePoint, and exposure to SAP.

Requirements

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
Bachelor’s degree in microbiology, Biology or Biotechnology or equivalent
SAP: 0–2 years (exposure required)
LIMS & GMP laboratory data review: 3–5 years
Microsoft SharePoint: 3–5 years
Microbiology assays data review (Bioburden, Endotoxin, Sterility, EM, Media Qualification)
Deviation, CAPA, SOP, and investigation writing
ALCOA+ data integrity compliance

Nice To Haves

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

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.