SOKOL GxP Services ยท 1 month ago
QC Microbiology Data Reviewer & GMP Documentation Specialist
Indianapolis, IN
Contract
Onsite
Mid Level
$47/hr - $55.90/hr
4+ years expSOKOL GxP Services is seeking a QC Microbiology Data Reviewer & GMP Documentation Specialist to support GMP microbiology operations. The role involves independent review of microbiology data and documentation to ensure accuracy and compliance with ALCOA+ principles.
Pharmaceuticals
No H1B
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
Qualification
Required
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
Preferred
Preferred training in Quality systems, cGMP, and Data Integrity
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
Health Insurance
Holiday Pay
401(k) Program
And Other Benefits
Employee referral bonus program
Company
SOKOL GxP Services
SOKOL GxP delivers cost-effective Commissioning, Qualification, and Validation (CQV) services for pharmaceutical, biotech, and cell therapy companies.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase