Summary :

The IT Quality specialist I is primarily accountable for computer systems validation (CSV) activities within the country they reside in or where the scope and impact of the system is small scale. This position will assist software validation initiatives for the BioPharma Laboratory Services (BLS) within the site and country. They 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

Duties and 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 Education required:

• Bachelor’s Degree or higher preferred (ex. science based, operations research, IT, technology, etc.)
• Experience may be considered in place of qualifications related certifications preferred (e.g. PMP, CQE, CQM, etc.)
• 1+ years’ experience in execution of projects, experience in partnering with/guiding internal clients to deliver on project goals
• 1+ years’ experience 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)

Skills and Competencies:

• 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.
• Speaking English required
• Writing/Reading English required
• 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

Labcorp is proud to be an Equal Opportunity Employer:

Labcorp strives for inclusion and belonging 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 and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), 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. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. 

We encourage all to apply

If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.