Specialist, Quality Assurance

Job Description This position contributes to the overall QA Program of the laboratory. Responsible for licensure, accreditation and inspection of the laboratory. Accountable for the internal and external quality assurance programs. Position coordinates efforts that promote quality and ensures that all pre‑analytical, analytical, and post‑analytical processes within the QMS are compliant with CAP, CLIA, ISO 15189 and various State Licensure requirements and all other applicable regulatory or certification bodies. Functions as the representative for the Quality Assurance department to both internal and external functions. Responsibilities Ensure all State Licensure for NY, CA, PA, RI, Maryland and others are maintained in good order, renewing annual licenses, managing the CAP database and ensuring information is current and reviewed periodically. Manage and facilitate submission of assays, permits and categories for NYS. Provide guidance for various State requirements and standards. Coordinate NYS onsite inspections with the laboratory and assist with inspection readiness. Conduct internal audits to ensure laboratory is inspection ready at all times and prepare corresponding reports. Manage State reportable program for various tests and work closely with other laboratories and the Quality & Regulatory team. Manage the Cancer Registry Program and collaborate with SMEs and the Quality & Regulatory team. Assist with external audits. Review protocols and recommend enhancements to the QA Program. Coordinate compliance with applicable regulations through documentation, audits, and corrective action. Review departmental quality records and collaborate with management to investigate and resolve nonconformances. Audit the training and competency program. Review and approve non‑conformances and follow up with owners to ensure corrective actions and preventive actions (CAPA) are implemented and sustained. Report Promptly Reportable Quality Issues and Revised and Amended Reports in compliance with the SOP. Communicate effectively with Lab Managers, Supervisors, and Quality Coordinators to promote quality of the local business unit and Quest Diagnostics Lab. Serve as a resource for laboratory inquiries concerning CAP, CLIA, ISO, and other applicable regulatory or certification bodies. Monitor that testing personnel have appropriate licensure, accreditation, and that duties are delegated per regulations. Write or review General Standard Operating Procedures for the Quality Assurance department or laboratory services. Support and comply with all company policies and procedures. Promote continuous quality improvement by collaborating with management to implement standardization and process improvement. Participate in quality‑oriented projects as assigned. Perform other duties as assigned to meet business needs or customer requirements. Qualifications Minimum of 4–5 years of clinical laboratory experience. Preferred: Previous experience with Quality Assurance. Physical and Mental Requirements May require lifting and carrying objects from 1 to 10 pounds frequently, 11 to 25 pounds occasionally, 36 to 50 pounds seldom, and over 50 pounds without assistance. Ability to sit or stand for long periods of time. Knowledge Knowledge of CAP, CLIA, GLP, and ISO standards and regulations. Basic theoretical and operational knowledge in quality assurance and laboratory operations. Knowledge of organizational and departmental policies and procedures. Knowledge of current local, state, and federal requirements. Demonstrates initiative, problem‑solving skills, teamwork, and interdepartmental collaboration. Skills Demonstrate leadership skills through accountability, integrity, and collaboration. Excellent interpersonal and communication skills (oral and written). Project a positive, professional demeanor. Communicate in a manner that creates an informed, positive environment. Facilitate teamwork and change initiatives. Detail‑oriented, able to work independently, set priorities, and handle multiple tasks simultaneously. Strong organizational and prioritization skills. Proven problem‑solving skills with the ability to develop appropriate resolutions. Proficiency in Microsoft Office (Word, Excel, Outlook) and Laboratory Information Systems. Education Bachelor’s Degree (BA/BS) in a Life Science or equivalent combination of education and experience. (Required) Licenses and Certifications ASCP Certification and ASQ Certified Quality Auditor (CQA) – Preferred. 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. #J-18808-Ljbffr Quest Diagnostics