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 focus on ensuring order-to-result workflows and audit trails meet GxP, CLIA, HIPAA, and 21 CFR Part 11 requirements.

In my current role, I execute UAT for Sunquest LIS, CoPath, and Quanum upgrades, validating system behavior and 21 CFR Part 11-compliant audit trails before production release. I also pull audit trail reports to support CAPA investigations and verify electronic signatures and timestamp integrity.

I’ve built a track record of strong quality outcomes, including conducting 65+ internal audits against SOPs and CLIA standards with zero repeat findings. I’ve managed case exceptions in Collab, tracked defects in JIRA, and supported resolution of 200+ issues while testing end-user workflows against current SOPs.

Previously, I supported LIMS migrations through UAT, contributed to reduced record retrieval time from 5 days to 2 days, and trained 15+ staff on GxP and CLIA standards. Earlier, I improved specimen processing by 30% and reduced equipment downtime 25% through systematic equipment testing, troubleshooting, and QC documentation reviews.