Senior Quality Assurance Specialist – Computer Systems, Data Integrity

🔥 4 minutes ago

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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LabConnect

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2002

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

💰 $24.5M Series A - LabConnect on 2017-06

Healthcare • Pharmaceuticals • Biotechnology

LabConnect is a global central laboratory solutions partner that provides technology-driven, customized, orchestrated, and scalable laboratory and data services to support clinical trials and drug development worldwide. Its offerings include central and specialty bioanalytical testing, radiopharmaceutical support, decentralized/near-home collection, custom collection kits and high-volume kitting, companion diagnostics and assay validation, data management and harmonization, regulatory and scientific project management, and commercial/post-market support. LabConnect serves sponsors and CROs across multiple therapeutic areas (oncology, vaccines, cell and gene therapy/ATMPs and more), emphasizing program oversight and operational execution for clinical research.

📋 Description

• 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

• 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

• Minimal travel requirement • Remote work arrangement