Specialist, Quality Assurance

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.

Travel: 26-50% (Between NJ and NY)

This is an Onsite position at our Clifton, NJ Lab

• Licensing and Accreditation 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.
• Proficiency Testing 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 resubmission program, if applicable.
• Assist in maintaining a defined instrument-to-instrument, method-to-method, and laboratory-to-laboratory comparison process.
• Quality Assurance/Quality Improvement Support and assist on monthly Quality Assurance (QA) meetings. Support each department's comprehensive Quality Management Plan (QMP). Assist in maintaining and monitoring Quality Assurance specific quality indicators.
• Facilitate the Implementation, distribution and review of the Corporate and local QA initiatives.
• Support the Corporate Programs: Patient Results Distribution, Inter-lab QC, Best Practice Team Initiative/Database Changes Verification Program and other monitoring programs specifically assigned by Corporate Quality Assurance.
• Facilitate agency/patient complaints and response process.
• 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 any other duties as assigned by the Technical Manager
• Serve as Quality Assurance Specialist supporting Main Laboratory and Rapid Response Laboratories (RRLs) across all relevant areas.

Required Work Experience:

• At least four years employment in a clinical laboratory
• Experience with Quality Assurance, statistical Quality Control, and laboratory regulations/accreditation requirements required.

Competencies:

• Strong interpersonal communication skills required Demonstrated strong writing and composition skills required
• Demonstrated success in motivating team members to reach objectives desirable
• Strong influencing skills desirable Business Process Skills
• Understands clinical laboratory operations required
• Able to effect Quality Improvement through problem solving skills and knowledge of quality tools required
• Able to manage change required Organization skills required Project management skills required
• Analytical skills required
• Technical skills required
• Computer skills required
• Able to function in a matrix organization desirable
• Multi-tasking skills desirable

Education:

• Bachelor's degree (chemical, physical, biological or clinical laboratory science or medical technology) required Certifications Qualification as General Laboratory Supervisor as defined by CLIA '88and NYSDOH and NYSDOE.

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