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Description

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.

Requirements

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.

Benefits

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