• Validation Specialist I (Software Quality)

    Job Location US-NC-Chapel Hill
    Regular Full-Time
  • Overview

    The Validation Specialist will perform business analysis, validation, and testing processes required to support the software development and implementation process in the regulated clinical research field.  This individual will work closely with business primes to define and document requirements and business processes that drive the features in the software used to support various segments of the clinical trials process.  This individual will direct validation testing of ensuring final outcomes meet specified requirements, and will ensure and facilitate corporate compliance with applicable regulations as they affect software development, implementation and maintenance in a regulated environment, including participation in audits as they pertain to software projects and systems.



    The responsibilities of this position fall into four major categories - project coordination, documentation management, regulatory compliance, and validation testing.

    • Identify and schedule project deliverables, milestones, and tasks required to validate software releases
    • Research, develop, and write content for the validation of software products and services
    • Prepare and maintain documentation and publications relating to users, systems, programming, operations, products, services, testing and validation
    • Create graphical images, flow charts, and diagrams for inclusion in documentation
    • Lead and/or participate in developing SOPs (Standard Operating Procedures) that are followed to ensure regulatory compliance in developing or implementing software
    • Ensure adherence to SOPs, regulatory validation, and quality assurance plans by software developers and their customers
    • Act as an independent quality reviewer for peer software validations as well as openly accept critical quality reviews of one’s own work with the goal of producing high quality documentation to support audits
    • Ensure that developed application documents meet all project and SOP requirements
    • Ensure compliance with testing environment requirements for validation testers
    • Create and/or execute acceptance tests for software under development and/or commercial off the shelf software products
    • Coordinate the recruitment, training, and testing of qualified testers to perform acceptance testing for new software releases


    • Bachelor's degree (BA or BS) and a minimum of one year of professional work experience is required
    • Working knowledge of 21 CFR Part 11 regulations and a project management background is preferred
    • Experience with Microsoft Word, Microsoft Visio, Microsoft PowerPoint, Microsoft Project, Microsoft SharePoint, Microsoft Excel and Adobe Acrobat
    • Strong writing and documentation skills
    • Must be detail-oriented, have strong organizational skills and be able to multi-task
    • Ability to quickly learn new techniques or skills that are needed for projects
    • Ability to work as part of a cross-disciplinary team and to communicate and relate to a diverse number of co-workers. 



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