Validation Specialist II / III

The Validation Specialist II / III will perform business analysis, validation, and testing processes required to support the software development and implementation process in the regulated clinical research field. The Validation Specialist II also directs the validation testing of ensuring final outcomes meet specified requirements. Lastly, this position ensures and facilitates 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. Responsibilities 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 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