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. 

Responsibilities:

Licensing and Accreditation  

• Support the internal and external 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.  
• Assist testing departments with maintenance of defined instrument-to-instrument, method-to-method, and/or laboratory-to-laboratory comparison process.  

Quality Assurance/Quality         

• Improvement Support and assist 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, 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 specifically assigned by National Quality Assurance or other 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.  

Qualifications:

Required Work Experience:  

• Qualification as General Laboratory Supervisor as defined by CLIA '88 is required.  
• At least three years’ employment in a clinical or hospital laboratory setting is required.  
• Experience with Quality Assurance, statistical Quality Control, and laboratory regulations/accreditation requirements is required. 

Preferred Work Experience: 

• Experience with Data Analytics and strong excel background is preferred. 
• Experience with power point is preferred. 

Skills: 

• Strong interpersonal communication skills are required.  
• Demonstrated strong writing and composition skills are required.  
• Working knowledge of clinical laboratory operations is required.  
• Implementation of quality improvement projects through the application of problem-solving skills and knowledge of quality tools is required.  
• Analytical skills, as applied to quality tools, are required.  
• Technical skills, within the clinical laboratory, are required.  
• Comfort with using computers and computer applications is required. 
• Candidate functions in a matrix organization is desirable.  
• Multi-tasking skills are desirable. 
• Demonstrated success in motivating team members to reach objectives is desirable. 

Travel: 

26-50% (Day Travel between sites)

EDUCATION: 

Bachelor's Degree Required 

44859

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