Ashley User

Performed IT compliance and audit engagements for small businesses, assessing governance structures, control environments, and alignment to NIST, ISO 27001, HIPAA, and PCI DSS. Developed risk registers/control matrices, executed sampling-based control testing, and authored executive-ready audit reports with prioritized POA&Ms.

Directed compliance under a regulated Quality Management System (QMS), aligning operations with CAP/CLIA standards and external audit requirements. Led CAPA investigations, established SOP-anchored preventive controls, oversaw training, and validated LIMS upgrades through UAT while maintaining a control/evidence matrix and risk register.

Translated regulatory controls into enforceable processes for the InVision First platform by defining test and acceptance criteria and strengthening documentation traceability. Improved PHI chain-of-custody through LIMS governance and built a requirements-to-evidence traceability matrix to support efficient auditor walkthroughs and RFI closures.

Executed compliance-driven testing under CAP/CLIA and produced inspection-ready validation packages. Ran LIMS UAT, authored validation summaries for external audit submissions, and performed record sampling/spot-audit checks on deviations, CAPA closures, and training attestations.

Conducted root-cause investigations and documented risk treatments aligned to audit methodology. Coordinated instrument validations and LIMS (LabMatrix) UAT to validate data integrity/security and created defensible audit evidence (FDA/CAP) while maintaining audit checklists and an evidence index to support walkthroughs and management responses.

CISA certification is in progress.

Earned the CompTIA Security+ certification in cybersecurity.

Completed the Google Cybersecurity Certificate focused on core cybersecurity concepts and practices.

Earned a Bachelor of Science in Biological Sciences from North Carolina State University.