IT Assurance Analyst, QMS Applications

🕒 il y a 11 jours

🤠 Texas – Distant

🤠 Texas – Remote

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

🧐 Analyste

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ICU Medical

Site WebLinkedInTous les Emplois

5001 - 10000 employés

⚕️ Assurance santé

💊 Pharmaceutique

Healthcare Insurance • Pharmaceuticals • Medical

ICU Medical est un leader mondial de la thérapie intraveineuse (IV), spécialisé dans les produits et technologies médicaux innovants qui améliorent la sécurité et l'efficacité de la thérapie IV dans divers environnements de soins. Fondée en 1984 par des cliniciens, l'entreprise s'engage à fournir des solutions cliniquement pertinentes, y compris des pompes à perfusion, des logiciels de sécurité et des dispositifs d'accès vasculaire. L'engagement d'ICU Medical à améliorer les soins aux patients se reflète dans leur portefeuille complet qui couvre la thérapie de perfusion, la gestion des voies respiratoires, la surveillance hémodynamique et la gestion de la température, garantissant que les cliniciens peuvent relever efficacement les divers défis des soins aux patients.

Description

• The IT Assurance Analyst provides CSV/Assurance support for computerized systems, networks and software that have been newly installed, upgraded and/or modified to support cGMP functions in Manufacturing, Supply Chain, and Quality, as part of IT Quality and Compliance organizations. • This role works closely with Change Owners to generate and support validation/assurance testing (IQ, OQ, IOQ, PQ etc.) that are compliant with Plant and Corporate policies and procedures. • Responsible for reviewing, executing, documenting and approving assurance testing/validation deliverables, and if necessary, coordinate other resources in validation documents and activities.

🎯 Exigences

• Working knowledge of Oracle Agile PLM and Oracle EBS required. • Working knowledge of data migration and sampling methods preferred. • Process improvement training preferred. • Resourcefulness and problem‑solving skills, with the ability to navigate identify inefficiencies and ambiguity, remove obstacles, and deliver outcomes through innovative, forward‑thinking planning needed. • Experience in one of the following disciplines required: Quality, Manufacturing, Facilities/utilities, Pharma/Solution processes, Sterilization, IT Applications and/or Controls systems/software. • Experience and functional knowledge of Good Automated Manufacturing Practice (GAMP), cGMP, SDLC, Risk Assessment, EU Annex 11, ISO 13485 and/or 21 CFR Part 11 Electronic Records and Electronic Signatures needed. • Good organizational, presentation, meeting facilitation, and technical writing skills required. • Attention to details and the ability to proofread and audit validation documents required. • Familiarity with automation tools preferred.

🏖️ Avantages

• Must be at least 18 years of age. • Bachelor's degree in Computer Science, Information Systems, Engineering, or a related field from an accredited college or university is required. • Experience in ERP systems development, change, implementation, and lifecycle management – preference to Oracle EBS and Agile applications. • 4+ years of experience in Computer System Validation/ testing in one of the following – Manufacturing, Lab/Facilities, Pharma/Solution processes, Sterilization, Controls systems. • Familiarity with regulatory requirements related to 21 CFRs - Part 11, 820, 210/211, EU Annex 11 and ERES/ Data Integrity requirements. • Experience working with SOX, Data Privacy and Security requirements a plus. • Ability to collaborate and communicate with a variety of key stakeholders (IT, Manufacturing, Quality, Supply Chain, Logistics, Finance, Internal Audit). • Familiarity with Test Management tool (e.g., ValidationMaster), MS Excel and/or SQL queries preferred. • Demonstrable experience of working well in a dynamic, demanding environment with minimal supervision and high resourcefulness. • Demonstrable experience in balancing multiple priorities and delivering timely, high-quality outcomes.