Spec, Quality Assurance

Position Title: Administration - Spec, Quality Assurance

Work Location: Clifton, New Jersey, United States, 07012

Assignment Duration: 6 months

Work Schedule: Day Shift (8 AM - 4:30 PM)

Work Arrangement: Not specified

Position Summary: Support and coordinate efforts that foster quality and ensure that all preanalytical, analytical and postanalytical processes are consistent with our company values and mission.

Key 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 clients 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 instrumenttoinstrument, methodtomethod, and laboratorytolaboratory comparison process.
• Quality AssuranceQuality Improvement Support and assist on monthly Quality Assurance QA meetings.
• Support each departments 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 InitiativeDatabase 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.
  
  Qualification & 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 and accreditation requirements required.
• Bachelors Degree Chemical, physical, biological or clinical laboratory science or medical technology
• 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
• Multitasking skills desirable
• Demonstrated success in motivating team members to reach objectives desirable
• Works in a biohazard environment