Quality Assurance Specialist

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.
Duties and Responsibilities
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 *** 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 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. 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.

Job Qualifications (Work Experience, Physical & Mental Requirements, Knowledge, Skills)
Required Work Experience:
Qualification as General Laboratory Supervisor as defined by CLIA '88required
At least three years employment in a laboratory setting required
Experience with Quality Assurance, statistical Quality Control, and laboratory regulations/accreditation requirements required.
Preferred Work Experience:
N/A
Physical and Mental Requirements:
N/A
Knowledge:
N/A
Skills:
Strong interpersonal communication skills required
Demonstrated strong writing and composition skills required
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
Demonstrated success in motivating team members to reach objectives desirable

Works in a biohazard environment

Bachelor's Degree - Chemical, physical, biological or clinical laboratory science or medical technology -REQUIRED

Certifications Qualification as General Laboratory Supervisor as defined by CLIA '88 is REQUIRED