CLS QC Lab

Duties

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Research and address the most complex and exacting regulatory and accreditation compliance issues, including issues related to cutting edge policy and practice of laboratory administration and science.

Participate in Department and Directorate-level planning and assist in the formulation of strategy and tactics related to laboratory capabilities, capital equipment acquisition, staffing and personnel strategies.

Ensure that all other elements of Good Laboratory Practices (and, where applicable, Current Good Manufacturing Practices) not otherwise mentioned are maintained.

In addition to routine diagnostic work, focus attention on strategic planning, complex problem-solving, personnel management, technique development, research, and maintaining compliance with myriad standards and regulations.

Plan, implement, and coordinate state-of-the-art quality control programs, and ensure participation in acceptable proficiency testing programs in all areas of laboratory medicine.

Ensure that quality control and quality assurance programs are established and maintained to ensure the quality of lab services provided to identify failures in quality as they occur.

Plan and conduct studies on technical and administrative problems involving personnel shortages, organizational structure, new technology, program deficiencies, reporting systems, etc.; recommends changes based on findings.

Assess operating costs and develop budget input.

Ensure that testing systems developed and used for each of the tests performed in the lab provide quality laboratory services for all aspects of test performance, which includes the pre-analytic, analytic, and post-analytic phases of testing.

Ensure all remedial actions are taken and documented whenever significant deviations from the lab's established performance characteristics are identified and that patient test results are reported only when the system is functioning properly.