Spec, Quality Assurance

Description

Shift/Time Zone: Day Shift (8 AM - 4:30 PM)

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.

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 client 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