Overview
Impact : Discover a role that empowers some of life's most important healthcare decisions.
Category : Corporate Location : Marietta, Georgia Job function : Operations Job family : Strategy / Process Excellence
Job Description
This is a hands-on, lead from the front position that requires the development and documentation of GxP compliant processes to maintain all aspects of test code management for the Pharma Services group. You will perform these procedures while creating the team's resource requirements as the business grows. Once the resource plan is executed you will manage the team remotely across multiple time zones and potentially internationally.
Responsibilities
- Develop, document and maintain processes in compliance with the appropriate GxP regulations and the Pharma Services QMS system, including :
- Test Code Creation (TCC) intake
- TCC prioritization, scheduling & assignment
- TCC design and approval
- TCC development and validation
- TCC approval and release
- Provide QCTMS production support, creating and maintaining test codes, while developing resource plans and building out the team.
- Oversee and guide the TCC team once in place to implement new and updated test codes throughout the test code lifecycle.
- Work with Pharma Services Proposals, Project Management, Data Management and Senior Leadership to prioritize and maintain a published schedule of test code deployments.
- Follow test updates from partner laboratories and assess when updates are required to the test compendium.
- Work with partner lab teams and IT to ensure test information is appropriately routed between systems.
- Work with partner lab and medical teams to ensure test information is appropriately displayed on laboratory reports.
- Aid in the due diligence of future selection of partner labs by evaluating their test compendium and its mapping to the Pharma Services test compendium.
- Other duties as assigned.
Qualifications
Required Work Experience :
5+ years of experience in laboratory, biopharma, and / or diagnostic industry in multiple lab disciplines, working with an automated Laboratory Information System.Preferred Work Experience :
3+ years working on supporting and / or administrating a healthcare informatics system in a clinical or diagnostics lab environment.Physical and Mental Requirements :
Office work and periodic travelKnowledge :
Knowledge of laboratory testing processes.Knowledge of regulatory frameworks associated with clinical laboratories and clinical trials, such as CAP, CLIA, GxP and 21CFR Part 11Understanding of system integrationsUnderstanding of data transfersSkills :
Ability to manage complex cross-functional projectsCritical thinking and problem-solving skillsQuantitatively inclinedStrong communicationsRequired :
Direct leadership of internal and / or external resources managed remotely.Travel : Domestic up to 25%; international up to 25%A bachelor's degree or higher or equivalent experienceEnglish requiredPreferred :
Master's Degree or EquivalentCompany and Compliance Information
44176
Quest Diagnostics honors our service members and encourages veterans to apply.
Equal Opportunity Employer : Race / Color / Sex / Sexual Orientation / Gender Identity / Religion / National Origin / Disability / Vets or any other legally protected status.
Quest Diagnostics is an equal employment opportunity employer. Our policy is to recruit, hire and promote qualified individuals without regard to race, color, religion, sex, age, national origin, disability, veteran status, sexual orientation, gender identity, or any other legally protected status. Quest Diagnostics observes minimum age requirements established by federal, state and / or local laws, and will ask an applicant for verification when deemed necessary.
Quest Diagnostics is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please complete the accommodation request form.
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