Saxon White

I’m a Lab Operations professional with 5+ years in regulated diagnostics, including 3+ years supporting Quality Assurance testing, audits, and system validation. I apply quality processes in GxP environments to protect patient data and ensure reliable order-to-result workflows.

Hands-on with Sunquest LIS, CoPath, Quanum, Atlas, QLS, and Collab, I execute UAT for system upgrades and validate 21 CFR Part 11-compliant audit trails before production release. I pull audit trail reports for CAPA investigations, verify electronic signatures and timestamp integrity, and manage case exceptions to support QA review.

I conduct 65+ internal audits against SOPs and CLIA standards with zero repeat findings, documenting deviations and verifying CAPA effectiveness through closure. I’ve also managed defect lifecycles in JIRA, documented issues, retested after IT fixes, and supported resolution of 200+ issues.

I started in specimen processing—accessioning, aliquoting, and data entry—while maintaining chain-of-custody per CLIA and HIPAA, then progressed into QA support through demonstrated execution of quality processes. I’ve trained 15+ staff on GxP standards and CLIA requirements and onboarded 10+ technicians, while supporting continuous compliance through equipment calibration testing and performance verification.