QC Microbiology Data Reviewer & GMP Documentation Specialist

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