Specialist, Quality Assurance

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

This is an onsite position. (5 days)

Travel: Up to 25% required.

Grade: 47

Licensing and Accreditation

• Support the internal inspection process of the business unit, associatedlaboratoriesand 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 Samplesresubmission 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 Improvement (QI) plan. Assist in maintaining and monitoring Quality Assurance specific quality indicators.
• Facilitate the preparation,distributionand review of the QA Manual.
• Support the Corporate Quality Surveillance Program, Patient Results Distribution Program, Best Practice Team Initiative/Database Changes VerificationProgramand other monitoring programs specifically assigned by National Quality Assurance. Quality Assurance Initiatives
• 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.

Required WorkExperience:

• Qualification as General Laboratory Supervisor as defined by CLIA '88required
• At least three years employment in a laboratory setting of high complexity testing is required.
• Experience with Quality Assurance, statistical Quality Control, and laboratory regulations/accreditation requirementsrequired.

Skills:

• Strong interpersonal communication skillsrequired
• Demonstrated strong writing and composition skillsrequired
• Understands clinical laboratory operationsrequired
• Able to effect Quality Improvement through problem solving skills and knowledge of quality tools required
• Able to manage changerequired Organization skillsrequired 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
• Demonstrated success in motivating team members to reach objectivesdesirable

Education

• Bachelor's degree in chemical, biological or clinical laboratory science or medical technology required.