Hiring: Senior Quality Assurance Specialist – Computer Systems and Data Integrity Company: LabConnect Location: Johnson City, TN Job Posted Time: 2026-09-10 12:26:55 Target Skills & Keywords : GCP, HIPAA, Microsoft Office, Microsoft PowerPoint, Quality Assurance, Regulatory Compliance, Root Cause Analysis, Vault About the job Experience: •Recognized IT auditor, Certified Auditor accreditation or information security qualification (e.g. CISA, QICA, CISSP, CRISC, ISO27001 Lead Auditor, SSCP) preferred. •Demonstrated capacity to take the initiative, dependable, and work with little supervision while being resilient to change •Demonstrated capacity to work within a fast-paced, cross-cultural, and cross-functional team environment •Demonstrated capacity to adhere to established timelines, processes and procedures •Strong planning and problem-solving skills. Required Skills: •Plan and perform audits of IT and technology vendors, Review audit findings and validation reports to assess compliance gaps and system risks. Actively participate in root cause analysis (RCA) sessions and collaborate with cross-functional SMEs to agree/approve robust and effective Corrective and Preventive Actions (CAPAs). •Assist with risk assessments of new and proposed technologies including contributions to Artificial Intelligent (AI) advisory team. •Create, Approve and ensure internal LC SOPs and processes are designed for regulatory compliance as applicable to computerized systems and data integrity, data privacy (e.g. GxP, FDA 21 CFR Part 11, and EU Annex 11). •Ensure proper documentation for CSV and Data Integrity projects, including risk control metrices, compliance assessments, process narratives, testing, issue evaluation, and reporting. •Manage and execute day-to-day compliance operational tasks, including client and vendor IT questionnaires, compliance metrics reporting, audit finding responses, internal audits, and document reviews. •Conduct comprehensive IT supplier qualification reviews to assess the compliance, reliability, and data integrity practices of third-party vendors. •Ensure life cycle management of GxP Computerized systems through QMS policies, documentation and change control. •Prepare KPIs in support of quality reporting to management. Assist in other QA tasks as assigned, including Veeva Vault workflows, reporting and configurations. Qualifications: •Bachelor’s degree in information technology or related field; and 6 years of relevant experience 4+ years of experience working in at least one of the following regulatory settings: FDA 21 CFR 11, Annex 11, ISO 27001, SOX, HIPAA, HITECH, CLIA, CAP, GCP . Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!