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.
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.
Required 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;
Education:
- Bachelor’s degree in microbiology, Biology or Biotechnology or equivalent;
- Preferred training in Quality systems, cGMP, and Data Integrity.
Skills:
- 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.
Competitive hourly rate: $47 – $55.9/hr (W-2 only, no C2C)
Working Hours: Monday - Friday, regular business hours
12-month contract with possible extension
Health insurance, holiday pay, 401(k) program, and other benefits
Employee referral bonus program
