Senior Clinical QA Specialist

🕒 Julho 27

🌐 Argentina, Brasil, +4 outros países – Remoto

🇦🇷 Argentina – Remoto 🇧🇷 Brasil – Remoto 🇨🇷 Costa Rica – Remoto 🇨🇴 Colômbia – Remoto 🇵🇪 Peru – Remoto 🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

🔧 Engenheiro de QA (Qualidade de Software)

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EDETEK Inc.

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2009

💊 Farmacêutico

🧬 Biotecnologia

☁️ SaaS

Pharmaceuticals • Biotechnology • SaaS

A EDETEK Inc. é uma empresa de informática de desenvolvimento clínico que fornece um ecossistema de nuvem nativo para I&D e uma plataforma eClinical integrada para apoiar ensaios clínicos e submissões regulatórias. Seu portfólio de produtos inclui ferramentas de orquestração e colaboração CONFORM™, uma suíte eClinical (CTMS, EDC, ePRO/eCOA, RTSM), hubs de integração de dados e metadados, um data lake clínico e ambientes prontos para computação estatística e submissão. A EDETEK também oferece serviços — bioestatística e programação, gestão de dados clínicos, desenvolvimento de estudos clínicos, redação médica e operações eClinical — voltados para patrocinadores das indústrias farmacêutica, de biotecnologia e de dispositivos médicos. A empresa enfatiza interoperabilidade, qualidade de dados e capacidades habilitadas por IA para acelerar a execução de estudos e submissões regulatórias globalmente.

Descrição

• We are seeking a senior QA specialist who will play a critical role in driving compliance and quality across the organization’s biometric services and computer systems. • This role involves hands-on execution of QA activities, leadership in audits and risk management, and close collaboration with cross-functional teams such as data management, biostatistics, statistical programming, software development and validation, and IT and security. • The senior QA specialist will ensure that processes, computer systems, and deliverables adhere to GxP, ICH-GCP, 21 CFR Part 11, and other applicable regulations, as well as internal quality standards through proactive oversight, documentation review, system validation, and continuous process improvement. • Conduct and/or host internal audits and vendor audits. • Review and audit Trial Master File (TMF) for completeness, accuracy, and compliance. • Track and report audit findings, deviations, and CAPAs (Corrective and Preventive Actions). • Perform risk-based audit planning and inspection readiness assessments. • Review and assist in developing policies, SOPs, work practice documents, forms and other Quality Management System (QMS) documents. • Ensure alignment with the company’s Quality Policy and applicable external regulations. • Ensure controlled documents are reviewed periodically and in a timely manner. • Document and manage deviations, nonconformances, and CAPAs. • Maintain quality records and support archiving in accordance with regulatory timelines. • Collaborate with functional managers to establish and periodically review training curricula, including study-specific training for internal teams. • Monitor overdue training, and follow up with individuals and their supervisors until completion. • Participate in validation planning and execution for internal and customer-facing systems. • Collaborate with software validation team and IT to review computer system validation plan (CVP), functional/user requirements specifications, and risk assessments. • Plan, execute, and document internal process audits, project/study audits, and vendor audits. • Coordinate with biometric teams to ensure services are performed in accordance with applicable regulations and EDETEK SOPs, including following QC processes, proper document versioning, review and approval, and appropriate documentation and sign-off for deviations. • Lead or assist in pre-inspection readiness for regulatory audits (e.g., FDA, EMA, MHRA).

🎯 Requisitos

• Ability to communicate effectively in English (spoken and written) • Ability to work independently, take initiative, and meet deadlines • Capable of prioritizing and executing tasks in a high-pressure environment • Demonstrated collaboration skills across diverse teams and functions • Adaptable and productive in a dynamic, evolving environment • Proficiency with Microsoft Office applications • Bachelor’s degree in life sciences, computer science, or a related field • Minimum of 5 years of QA experience in clinical research, clinical systems, or regulated software environments • Strong knowledge of GxP, ICH-GCP, 21 CFR Part 11, Annex 11, and SDLC principles • Proven experience in conducting audits and managing CAPAs • Excellent documentation and communication skills • Preferred: Experience in a company offering eClinical or biometric services • Preferred: Familiarity with electronic QMS platforms such as ZenQMS

🏖️ Benefícios

• Benefits vary by country, but remain competitive. Below is a sample of the benefits offered to U.S. employees. • Choice of comprehensive Medical, Vision and Dental Insurance plans • Paid vacation time and sick days • Corporate holidays annually • Participation in the 401K Plan • Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc. • Health Advocate and Employee Assistance Program