Specialist, Quality Assurance

Job Description

Support and coordinate efforts that foster quality and ensure that all pre‑analytical, analytical and post‑analytical processes are consistent with our company values and mission.

This is an onsite position (Mon to Fri, 5 days). Travel requirement: up to 25%. Grade: 47.

• Support the internal inspection process of the business unit, associated laboratories and specimen collection sites to ensure compliance with applicable federal, state, and local regulations, College of American Pathologists (CAP) accreditation requirements, and Quest Diagnostics standards.
• Serve as a resource regarding Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) regulations and CAP accreditation standards.

• Assist and ensure enrollment and participation in proficiency testing for each test to include corrective action when necessary.
• Coordinate the validity check program and blind samples re‑submission program, if applicable.
• Assist in maintaining a defined instrument‑to‑instrument, method‑to‑method, and laboratory‑to‑laboratory comparison process.

• Improve and assist on monthly Quality Assurance (QA) meetings. Support each department’s comprehensive Quality Improvement (QI) plan. Assist in maintaining and monitoring QA specific quality indicators.
• Facilitate the preparation, distribution and review of the QA Manual.
• Support the Corporate Quality Surveillance Program, Patient Results Distribution Program, Best Practice Team Initiative/Database Changes Verification Program and other monitoring programs assigned by National Quality Assurance.
• Assist in the prompt and complete reporting of reportable quality issues in compliance with the Standard Operating Procedure (SOP).
• Assist in the complete tracking of revised reports in compliance with the SOP.
• Assist in other duties as assigned by the Technical Manager.

• Qualification as defined by CLIA '88 requirement for a Technical Laboratory Supervisor.
• At least 3–5 years experience in a high‑complexity laboratory setting.
• Experience with quality assurance, statistical quality control, and laboratory regulations/accreditation requirements.

• Strong interpersonal communication skills.
• Demonstrated strong writing and composition skills.
• Understanding of clinical laboratory operations.
• Ability to effect quality improvement through problem‑solving and knowledge of quality tools.
• Ability to manage change and organize tasks.
• Project management skills.
• Analytical skills.
• Technical skills.
• Computer skills.
• Ability to function in a matrix organization (desirable).
• Multi‑tasking skills (desirable).
• Demonstrated success in motivating team members to reach objectives (desirable).

• Bachelor’s degree in chemical, biological or clinical laboratory science or medical technology.
• ASCP or AMT certification (preferred).

Equal Opportunity

Employer:

Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.