IT Validation Support Specialist I

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Job description

Reporting to the Manager, Computer Systems Validation, the IT Validation Support Specialist level I is primarily accountable for computer systems validation (CSV) activities. This position will provide guidance for software validation initiatives for the Labcorp Drug Development business units and will liaise with IT Project Managers, business unit resources and business unit leadership to execute a project-specific IT validation strategy by coordinating and guiding CSV activities.

* Essential Job Duties: *

* Validation Strategy *

* Assist with establishing, reviewing, executing, and ensuring compliance with governmental regulatory requirements, policies, standards, and procedures related to processes for CSV and qualification of infrastructure components.
* Assist with the implementation of a common System Development Life Cycle (SDLC).
* Advise the project team on and be responsible for CSV strategy and documentation of product functionality across system releases.
* Coordinate project-specific CSV efforts, including coordination of the execution of the test plan.
* Recommend proper controls for the Labcorp's computer systems to ensure the reliability of applications and infrastructure, as well as the integrity of data and safety of subjects.
* Utilize tools for conducting and executing CSV.

* Testing *

* Provide direction to assure that applications and infrastructure components possess the necessary level of testing and required documentation to comply with applicable GxP regulations and client requirements/expectations.
* Ensure compliance with Labcorp standard testing methodologies, procedures, and practices.
* Prepare validation and test strategies for IT initiatives, and present to project teams.
* Work with project teams to identify test requirements and advise on the design of testing phases, as well as documentation of test plans & test case specifications to meet system needs.
* Advise on the performance of application, functional, usability, performance load-stress, & user acceptance tests.
* Ensure that the testing is completed on time and that it addresses all user and functional requirements as defined during the requirement definition process.
* Perform documentation reviews and conduct analyses of validation process issues and testing results.
* Ensure that software faults are identified and documented, and coordinate with development staff so that testing issues are isolated and resolved.
* Ensure that all necessary project-specific CSV documentation is produced, and for reviewing the material for correctness, completeness, and clarity.

* Partnerships *

* Liaise with the IT Quality function to develop and implement a continuous improvement model of the Labcorp's validation methodology and SDLC.
* Periodically conduct training for staff and business associates as to their respective responsibilities within the validation methodology.
Education/Qualifications:
* Bachelor's Degree or higher preferred (ex. science based, operations research, technology, etc.)
Experience:
* Entry level of experience preferred in execution of projects, experience in partnering with/guiding internal clients to deliver on project goals
* Creative approach to resolving technical issues, and balancing business needs
* Project Management experience - ability to plan, organize, and execute work across multiple initiatives to drive delivery of validation commitments
* Ability to coordinate strong teams, and manage multiple priorities
* Demonstrates self motivation to lead teams on a unified validation strategy, while achieving department goals, objectives, and initiatives
* Exceptional verbal, written, presentation, interpersonal skills, and ability to command respect of others.