IT Assurance Analyst, QMS Applications

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🤠 Texas – Remote

🤠 Texas – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧐 Analyst

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ICU Medical

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Healthcare Insurance • Pharmaceuticals • Medical

ICU Medical is a global leader in intravenous (IV) therapy, specializing in innovative medical products and technologies that enhance the safety and efficiency of IV therapy across various care settings. Founded in 1984 by clinicians, the company is dedicated to delivering clinically-relevant solutions, including infusion pumps, safety software, and vascular access devices. ICU Medical's commitment to improving patient care is reflected in their comprehensive portfolio that spans infusion therapy, airway management, hemodynamic monitoring, and temperature management, ensuring clinicians can meet the diverse challenges of patient care effectively.

📋 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.

🎯 Requirements

• 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.

🏖️ Benefits

• 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.