Ashley James

Performed IT compliance and audit engagements for small businesses, assessing governance structures, control environments, and alignment to NIST, ISO 27001, HIPAA, and PCI DSS frameworks. Developed risk registers and control matrices, mapping organizational policies and procedures to regulatory obligations and audit checkpoints. Conducted sampling-based control tests across access management, incident response, and change management; documented findings and recommended remediation aligned with risk appetite. Authored audit reports with executive-ready summaries, detailed evidence trails, and prioritized POA&Ms to guide remediation efforts. Partnered with clients to implement corrective actions, enhance compliance dashboards, and strengthen audit readiness for regulatory inspections and third-party reviews. Scoped and planned a HIPAA/ISO 27001 IT audit using NIST SP 800-30; built a risk register and control matrix prioritizing IAM, encryption, logging, and backup/DR. Executed sampling-based control testing in AWS/Azure (access reviews, key management, log retention, configuration baselines); performed walkthroughs and re-performance and captured verifiable artifacts in an indexed evidence binder. Issued an executive audit report with control ratings, residual-risk tiers, and a prioritized POA&M assigning owners, timelines, and acceptance criteria. Drove remediation by defining measurable KRIs (e.g., access review SLA, key rotation cadence, log retention coverage) and a follow-up test plan to validate sustainable closure.

Axis Security Solutions

Operates within the Quality Management System framework to ensure operational excellence, collaborating with Laboratory Manager to organize and schedule daily activities for laboratory staff Monitors production goals and quality indicators associated with sequencing runs; Conducts troubleshooting activities to ensure sequencing quality and resolve issues promptly Provides valuable workflow-related guidance as a Subject Matter Expert (SME) for the entire laboratory, overseeing a team of 7, with 3 direct reports, providing optimal performance Leads investigations on Corrective and Preventive Actions (CAPAs), documenting detailed analyses of lab issues; Drafts plan deviations and Standard Operating Procedures (SOPs) to enhance operational efficiency Assists in the creation of validation plans to adhere to quality standards; Reviews documentation for accuracy and compliance with Good Documentation Practices (GDP) Conducted User Acceptance Testing (UAT) for Laboratory Information Management Systems (LIMS) – specifically Labvantage, evaluated the functionality of the system, aligning with laboratory requirements; Provided evidence of test cases and accomplishments through detailed screenshots Assisted with assay validations and documentation.

Neogenomics

Supported troubleshooting initiatives to pinpoint root causes of issues and assess their impact on samples, providing swift resolution Managed the inventory of laboratory supplies and oversaw daily operations, collaborating closely with the supply chain group to identify shortages and rectify errors Conducted high-complexity laboratory testing on patient specimens, strictly adhering to protocols governed by standard operating procedures to maintain accuracy and reliability Engaged in cross-functional coordinated efforts to identify and address complex process issues, analyzing data from SOPs, Laboratory Information Management Systems (LIMS), data management programs, and instrument files Led instrumentation validations based on meticulously crafted test cases, ensuring the accuracy and reliability of laboratory instruments and equipment Conducted User Acceptance Testing (UAT) for Laboratory Information Management Systems (LIMS) – specifically LabMatrix, evaluated the functionality of the system, aligning with laboratory requirements Assisted with assay validations and documentation.

Interpace Biopharma Solutions

Certified in Cybersecurity (CC)

(ISC)2

Google Cybersecurity Professional Certificate

Google

AWS Certified Cloud Practitioner

Amazon Web Services

Security+

CompTIA