QC Microbiology Data Reviewer and Writer

Job Title: QC Microbiology Data Reviewer and Writer
Job ID: 25-11788
Location: Indianapolis, IN (Onsite)
Duration: 12 Months
Work Schedule: Monday - Friday, Business Hours (Weekends and Holidays as needed)

Key Responsibilities

• Perform an 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

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
• SAP experience preferred

Education:

• Bachelor's degree in microbiology, Biology, or Biotechnology or equivalent
• Preferred training in Quality systems, cGMP, and Data Integrity

Contact:
Sunny Rajput | sunny.r@sunrisesys.com | URL: www.sunrisesys.com