Senior Quality Assurance Specialist – Computer Systems, Data Integrity

LabConnect

Senior QA Specialist validating GxP computer systems and data integrity for regulated life sciences. Overseeing audits, compliance documentation, risk assessments, and lifecycle controls.

Posted 8/5/2026full-timeRemote • Tennessee • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Computer System Validation (CSV) and data integrity compliance within regulated environments, including FDA and ISO standards. Proficient in managing compliance operations, conducting audits, and collaborating with cross-functional teams to ensure adherence to quality and regulatory requirements.

Highest-signal resume keywords

Computer System Validation (CSV)Regulatory Compliance (FDA 21 CFR Part 11, EU Annex 11)Data Integrity Policies and ProceduresVeeva and LIMS ExperienceIT Auditing Certifications (CISA, ISO 27001 Lead Auditor)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Computer System ValidationData Integrity ComplianceRisk AssessmentAudit ManagementQuality Management Systems (QMS)CAPA ApprovalSOP DevelopmentMetrics ReportingLifecycle Management of GxP SystemsContinuous Quality Improvement

Soft Skills

CollaborationIndependent WorkCross-Functional TeamworkProblem SolvingCommunication

Tools & Technologies

Microsoft Office SuiteVeeva VaultLIMSDatabase SoftwareMS Project

Certifications & Qualifications

Certified Auditor AccreditationCISAQICACISSPCRISCISO 27001 Lead AuditorSSCP

Industry Keywords

Clinical TrialsBiotechPharmaceuticalRegulated EnvironmentsCompliance Standards

Tech Stack

Tools & technologies

Google Cloud PlatformVault

About the role

Key responsibilities & impact

Oversee Computer System Validation activities for newly implemented and modified systems throughout the software life cycle
Collaborate with IT and system owners on validation strategies, documentation, and deliverables
Plan and perform audits of IT and technology vendors
Review audit findings and validation reports to assess compliance gaps and system risks
Participate in root cause analysis sessions and approve effective CAPAs with cross-functional SMEs
Assist with risk assessments of new and proposed technologies, including contributions to the AI advisory team
Create and approve internal SOPs and processes for computerized systems, data integrity, and data privacy compliance
Ensure documentation for CSV and Data Integrity projects, including risk control matrices, compliance assessments, process narratives, testing, issue evaluation, and reporting
Manage day-to-day compliance operations, including client and vendor IT questionnaires, metrics reporting, audit finding responses, internal audits, and document reviews
Conduct IT supplier qualification reviews
Ensure lifecycle management of GxP computerized systems through QMS policies, documentation, and change control
Prepare KPIs for management quality reporting and assist with Veeva Vault workflows, reporting, and configurations
Identify and implement continuous quality improvement plans across computerized systems
Monitor regulatory and IT compliance developments and best practices

Requirements

What you’ll need

Bachelor’s degree in information technology or a related field
6 years of relevant experience
4+ years of experience in at least one regulatory setting, including FDA 21 CFR Part 11, EU Annex 11, ISO 27001, SOX, HIPAA, HITECH, CLIA, CAP, or GCP
Experience in clinical trials and clinical laboratory, biotech, or pharmaceutical environments
Experience with computerized systems lifecycle and data integrity policies and procedures
Experience with core IT applications in regulated environments, including Veeva and LIMS
Working knowledge of Microsoft Office applications, including word processing, spreadsheets, PowerPoint, MS Project, and database software
Ability to work independently and collaboratively in cross-functional teams
Ability to meet quality and regulatory requirements while meeting business needs
Recognized IT auditor, Certified Auditor accreditation, or information security qualification such as CISA, QICA, CISSP, CRISC, ISO 27001 Lead Auditor, or SSCP preferred
No supervisory responsibilities
Minimal travel required

Benefits

Comp & perks

Minimal travel requirement
Remote work arrangement