QC Microbiology Data Reviewer and Writer

Job Description

Duties and 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.

Education & Experience:

• Bachelor’s degree in microbiology , Biology or Biotechnology or equivalent.
• Preferred training in Quality systems, cGMP, and Data Integrity.
• Minimum 4 years’ experience in GMP microbiology laboratory data review.
• 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.
• Experience with CAPA and Deviations required.
• Exp directing next steps for actions using data–candidate should be able to drive next steps.

Knowledge & Skills:

• Knowledge of Bioburden, Endotoxin, Sterility, Media qualification, and Environmental Monitoring.
• Tech knowledge of Assays to determine corrections.
• Candidate should have sense of urgency to get things done correctly.
• Self Starter.

Interview Process:

• 1st is Teams Interview with manager, camera on.
• 2nd would be an onsite panel interview.