Senior Analyst, Quality Trust & Compliance

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🕒 Dezembro 4, 2025

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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Endpoint Clinical

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

🧬 Biotecnologia

⚕️ Seguro de Saúde

💊 Farmacêutico

💰 $1.700.000 Debt Financing em 2010-03

Biotechnology • Healthcare Insurance • Pharmaceuticals

A Endpoint Clinical é líder em soluções de Gestão de Randomização e Suprimento de Testes Clínicos (RTSM), especializada em transformar e acelerar testes clínicos com transparência, confiança e inovação. Sua tecnologia aumenta a eficiência e precisão na randomização de pacientes e gestão de suprimentos clínicos. Apoia uma variedade de áreas terapêuticas, proporcionando soluções personalizadas para grandes patrocinadores farmacêuticos, patrocinadores de pequeno e médio porte e Organizações de Pesquisa por Contrato (CROs). Sua tecnologia avançada e configurável otimiza os processos de teste, melhora a gestão de suprimentos de medicamentos e aprimora a experiência nos locais de testes, assegurando que os testes globais se mantenham no caminho certo.

Descrição

• A primary point of contact for resourcing and guidance of product release team • Provide QTC review and approval of in-process tasks related to product and/or service provision • Develop and oversee onboarding and training of Analysts on QTC product release team • Act as subject matter expert and point of contact for Software Development Life Cycle process • Develop, write, and revise controlled Validation Deliverables and in continuous improvement efforts and procedures and practices related to product release • Provide ad hoc training to Operations staff on compliance procedures associated with product release • Responsible to perform the following QTC product release duties • Generate, perform review, and maintain records of Validation Deliverables documentation and ensure compliance to procedures and processes. • Maintain validation documentation in QMS according with company procedures • Provide support to operations staff to develop, write, and revise controlled Validation Deliverables. • Act as primary QTC representative and resource to Operations staff with regards to product release • Maintain validation documentation in QMS according with company procedures • Assist in preparation, review, and maintenance of reports for identified product events • Participate in Root Cause Analysis meetings with the Operational staff and provide input on the identification and documentation of Corrective Actions/ Preventive Actions for events of discrepancy or failure of released product • Assist CAPA team in completion of outstanding CAPA items with the appropriate stakeholders as it relates to product release. • Support the Governance unit in preparation for External Audits related to product release. • Perform QMS documentation Quality Control (QC) reviews on controlled documents such as SOPs, Work Instructions and Policies as well as provide feedback to key stakeholders as needed.

🎯 Requisitos

• M.S. degree and minimum 2 years of related experience OR · BS/BA degree and minimum 4 years of related experience • Certification in Quality Assurance or Regulatory Affairs preferred • Minimum 2-4 years of relevant working experience within a regulated environment · Substantial working knowledge of FDA regulations (21 CFR Part 11, EU Annex 11) regulations and current industry best practices · Knowledge of U.S. and international regulatory standards and guidelines · Relevant experience preferably in the clinical trial industry, IRT, or CRO experience is highly desired. · Experience with a QMS and LMS preferred

🏖️ Benefícios

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