Senior Quality Assurance Specialist – Computer Systems, Data Integrity

🕒 5 dias atrás

🎸 Tennessee – Remoto

🎸 Tennessee – Remote

⏰ Tempo Integral

🟠 Sênior

🔧 Engenheiro de QA (Qualidade de Software)

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LabConnect

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

Fundada em 2002

🏥 Saúde

💊 Farmacêutico

🧬 Biotecnologia

💰 $24.500.000 Series A - LabConnect em 2017-06

Healthcare • Pharmaceuticals • Biotechnology

A LabConnect é uma parceira global de soluções laboratoriais centrais que fornece serviços laboratoriais e de dados orientados por tecnologia, personalizados, orquestrados e escaláveis para apoiar ensaios clínicos e o desenvolvimento de medicamentos em todo o mundo. Suas ofertas incluem testes bioanalíticos centrais e especializados, suporte radiofarmacêutico, coleta descentralizada/perto de casa, kits de coleta personalizados e kits em alto volume, diagnósticos complementares e validação de ensaios, gerenciamento e harmonização de dados, gerenciamento de projetos regulatórios e científicos e suporte comercial/pós-mercado. A LabConnect atende patrocinadores e CROs em várias áreas terapêuticas (oncologia, vacinas, terapia celular e gênica/MTAPs e mais), enfatizando a supervisão de programas e a execução operacional para pesquisa clínica.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• Minimal travel requirement • Remote work arrangement