Labcorp is seeking an IT Quality Specialist - Level I to join our team in Huntington, Harrogate or Eye on a hybrid basis.

Work Schedule

Monday – Friday 8 AM – 4:30 PM

Job Responsibilities

• Assist with reviewing, executing, and ensuring compliance with governmental regulatory requirements, policies, standards, and procedures related to processes for CSV and qualification of infrastructure components primarily within the country they reside.

• Assist and support the implementation of a common System Life Cycle (SLC).

• Help ensure documentation and processes align with internal policies, procedures and regulations.

• Support the project team and guide CSV strategy and documentation of product functionality across system releases.

• Coordinate small scale project-specific CSV efforts, including coordination of the execution of the test plan.

• Recommend proper controls for 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.

• Assist compliance with Labcorp standard testing methodologies, procedures, and practices.

• Prepare validation and test strategies for IT initiatives and collaborate with project teams.

• Assist 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.

• Assist in/be involved in 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.

• Assist in documenting software faults 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.

• Support the development and provide suggestions for continuous improvement model of the Labcorp’s validation methodology and SLC.

• Other duties and responsibilities as deemed necessary by management

Minimum Qualifications

• Bachelor’s degree in science, operations or Information Technology.

Preferred Qualifications

• Relevant certifications to include PMP, CQE or CQM.

Additional Job Standards

• Professional experience in the execution of projects, experience in partnering with/guiding internal clients to deliver on project goals.

• Experience may be considered in place of qualifications.

• Good knowledge in an FDA/MHRA/OECD (GXP) regulated industry (i.e. such as pharmaceutical, medical device, or biotechnology).

• Familiar with various validation methodologies (SLC), and their implementation in an IT organization

• Awareness of regulatory compliance requirements in the pharmaceutical and drug development industry (GXPs)

• Communication: Strong verbal and written communication skills for effective interactions with employees, customers, and higher management.

• Customer Service: work well in a team.

• Organizational Skills: Proficiency in managing multiple tasks, prioritizing duties, and maintaining organization in a dynamic environment.

• Adaptability: Being able to adapt to changes

• Time Management: Efficiently managing one's own time and the time of others to ensure project efficiency.

• Competent in the use of Microsoft Office

• Creative approach to resolving technical issues, and balancing business needs

• Program & Project Management experience – ability to plan, organize, and execute work across multiple initiatives to drive delivery of validation commitments

• Ability to coordinate 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

• General office environment/Remote (Hybrid).

• Flexibility in schedule to travel as necessary during non-business hours

• Travel requirements 10% of time

Benefits:

• Competitive salaries.

• No weekend work

• Wider benefits package including pension and generous holiday allowance

If you're looking for a career that offers opportunities for growth, continual development, professional challenge and the chance to make a real difference, apply today!

Labcorp is global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development laboratory capabilities, our nearly 70,000 employees combine cutting-edge innovation, science and technology to solve some of today’s biggest health challenges, accelerate life-changing healthcare breakthroughs and impact lives around the world.