Job Description

Role: Computer System Validation Specialist - Level I

Locations: onsite at Harrogate, Eye, Huntingdon, Shardlow or York

Type: Full-time contract / direct hire

Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. With more than 70,000 employees, we serve clients in more than 100 countries.

Reporting to the Global Manager, Computer System Validation or Supervisor, Computer System Validation, the Trainee Computer System Validation Specialist is primarily accountable for computer systems validation (CSV) activities at the site they reside. This position will provide guidance for software validation initiatives for the local Drug Development Labs business units within the site and will liaise with IT Project Managers, Business unit resources and business unit leadership to execute project specific IT validation strategy by coordinating and guiding computer system validation 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.

Why us:

Labcorp supported the pharmaceutical industry develop more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today.

We are also the world s biggest Central Lab, generating more clinical trial data than all other central laboratories combined.

Our Early Phase Solutions have proved to shave off 30 % time from lead candidate to Proof of Concept.

LabCorp/Covance were the first in receiving FDA approval to perform COVID19 tests using an at-home collection kit.

Labcorp have been named by Forbes as one of the World s Best Employers 2020.

Join us and see why we are uniquely positioned to offer you not only a job, but a stable, long-term international career, and why more than 90% of the top 20 global pharmaceutical companies are repeat customers.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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