Senior Quality Assurance Specialist - Quest Diagnostics

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. (Hybrid schedule: 3 days onsite/ 2 days from Home office)

Leadership

• Direct, advocate for and enable visibility and effectiveness of quality processes in collaboration with the laboratory, Logistics, Medical Quality, Commercial, and Patient Services.
• Ensure accountability within all areas of the business unit (pre-analytical, analytical and post-analytical) such that every employee consistently exhibits behavior that promotes and supports quality, with a primary focus on Patient Services customers and clients.
• Influence may be exerted both directly and indirectly through the management of liaisons and intermediaries, such as department managers and supervisors as well as the Quality Assurance (QA) staff.
• Oversee activities of the department, distribute/assign work, determine priorities, schedule QA tasks. 
• Perform supervisory functions for their assigned staff including interviewing, hiring, training and providing staff development through performance evaluation and corrective counseling.  

Licensing and Accreditation

• Assist 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. Review and ensure that corrective action is implemented when non-conformances are found.
• Monitor published guidelines for revisions to regulations and/or accreditation standards and ensure laboratory compliance. Serve as a resource regarding Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) regulations and CAP accreditation standards for all sites.
• Proficiency Testing Identify all tests performed and ensure enrollment and participation in external proficiency testing for each test. For those tests not covered by external proficiency testing, ensure internal proficiency testing is performed. Ensure that all proficiency testing is reviewed and corrective action is complete for all non-conformances.
• Ensure that a defined site-to-site comparison process, with fixed criteria for accessing acceptability, is performed and documented at least semi-annually.

Quality Assurance/Quality Improvement

• Ensure that each department has a comprehensive Quality Improvement plan with monitors and that each department communicates their metrics and implements appropriate actions.
• Monitor and improve Quality Assurance specific quality indicators, including but not limited to: Patient Experience, Reportable Quality Issues, Proficiency Testing outcomes, Tests Not Performed (TNP), and performance on DOH/CLIA/CAP inspections.
• Ensure a process is in place to resolve customer complaints regarding pre-analytical, analytical, and post- analytical issues.
• Ensure performance of required Corporate Quality Inspection Program, Patient Results Distribution Program, Best Practice Team Initiative/Database Changes Verification Program and other monitoring programs specifically assigned by Medical Operations and Quality (MOQ).
• Ensure enrollment and participation in external federal and state cytology proficiency testing as well as required educational programs.
• Proactively research, develop, pilot, and implement corrective and preventive actions (CAPA)

Quality Control

• Act as a contact for national Quality Control (QC) peer comparison programs and ensure enrollment and effective corrective action as appropriate. 

Quality Assurance Initiatives

• Ensure that all departments have a process to identify and evaluate the relationship of patient information to patient test results. Ensure the process is in place, up to date, distributed and that all personnel are in compliance.
• Ensure prompt and complete reporting Reportable Quality Issues in compliance with the Standard Operating Procedure (SOP) and ensure effective corrective action including issuance of revised reports as applicable.
• Ensure complete tracking of revised reports in compliance with the SOP and ensure effective corrective action.
• Ensure compliance with all Quest standards as required.
• Represent Patient Services as part of regional quality improvement team

Required Work Experience:

• Minimum of four years clinical experience with two years in Quality Assurance. Internal applicants must be in good standing and rated an Achieves or better during their annual performance appraisal within the last two years. 
• Experience implementing quality programs and enforcing regulations in clinical laboratory and pharmaceutical industries is preferred.    

Other:

• Must demonstrate effective communication and collaboration skills within department as well as with other functions within the company and third parties (ie.clients)
• Must have the ability to establish work priorities for self and others and handle several procedures simultaneously including troubleshooting instruments and other problems/issues.
• Ability to schedule and manage resources to meet department goals.
• Must protect patient confidentiality at all times.

Educational Requirements:

• Bachelor of Science in Medical Technology, Biology or Chemistry.
• Foreign educated candidates must provide a detailed credential evaluation from IERF (International Education Research Foundation).
• United States educated candidates must provide a detailed original transcript
• Knowledge and understanding of CLIA, CAP, and DOH regulations
• Experience with Lean Six Sigma a plus
• ASQ Certification a plus (CQA, CQE)                                   

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 status protected by state or local law. Quest Diagnostics observes minimum age requirements established by federal, state and/or local laws, and will ask an applicant for verification when deemed necessary.