Within the State Laboratory of Public Health at the Division of Public Health, this position serves as a Laboratory Quality Improvement Consultant on the Quality Assurance Team. Under the supervision of the Quality Assurance Manager, the Quality Improvement Consultant will work with the entire team to assure compliance with the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for a high complexity clinical laboratory, implement the facility’s quality management system, and participate in continuous quality improvement activities.
The Quality Improvement Consultant will provide oversight for the facility’s document control software; administer the facility’s environmental monitoring system; coordinate the completion of documentation for non-conforming events and assure implementation of corrective actions; assist with completion of facility-wide calibration/certification activities; and participate in internal audits. This position will work closely with staff from the facility maintenance team and technical laboratory areas. Lastly, this position will work closely with the laboratory systems administrator to ensure the LIS meets CLIA requirements.
The Laboratory Quality Improvement Consultant duties will include but are not limited to:
Administer the facility’s document control software. Provide software training to technical and administrative staff. Assure version control for all regulatory documentation.
Coordinate programming and routine review of facility’s environmental condition monitoring system.
Oversee calibration and certification activities for systems, equipment, and instruments across the facility.
Assure documentation of non-conforming events and implementation of corrective actions.
Perform internal audits to assure compliance with CLIA regulations for high-complexity clinical laboratories.
Work in a lab environment using chemicals and reagents. Participate in biohazard, chemical, radiation safety, and other education programs.
Collaborate with other departments and colleagues for problem solving.
Use statistical methods to perform routine reviews to ensure quality of laboratory data, reporting and documentation.
Assist laboratory information system (LIS) administrator in assuring that LIS meets data quality requirements regarding CLIA.
Project management for new test implementation to include LIMS build.
About the Division of Public Health and the State Laboratory of Public Health:
The NC Division of Public Health (DPH) works to promote and contribute to the highest possible level of health for the people of North Carolina – Everywhere, Everyday, Everybody.
At the State Laboratory of Public Health (NCSLPH), we provide medical and environmental laboratory services such as testing, consultation, and training, to public and private health provider organizations responsible for the promotion, protection, and assurance of the health of North Carolina citizens. The NCSLPH serves the entire state as a reference laboratory for difficult, unusual, or otherwise unavailable laboratory procedures and assists in the development, evaluation, and standardization of medical and environmental laboratory testing procedures. We provide training and consultation to improve and assure quality services in other laboratories and certify milk and water laboratories and milk analysts. Visit our website at http://slph.ncpublichealth.com to learn more.
To receive credit for all of your work history and credentials, you must list the information on the application form. Any information listed under the text resume section or on an attachment will not be considered for qualifying credit. Qualified candidates must document on the application that they possess all of the following:
Must be capable of meeting the Federal CLIA’88 personnel requirements for a technical supervisor in a laboratory performing high complexity testing.
Experience with quality management systems and quality improvement tools and techniques.
Experience with LIMS (laboratory information systems) and their QA and regulatory requirement.
Experience with laboratory equipment, instrumentation, and terminology of clinical laboratory testing.
At least one year of experience in a quality management role in a laboratory setting.
Extensive knowledge of quality assurance including proficiency testing, quality control requirements, and clinical laboratory procedures, as well as method verification and validation procedures.
Knowledge of document management and compliance software.
Excellent organization skills allowing the coordination of multi-faceted QA activities.
Experience with the STARLIMS laboratory information management system.
Experience with Qualtrax compliance software.
Physical Requirements: An occupational medical assessment may be required to determine your ability to safely work with biological, chemical, or radiological hazards.
This position may also require periodic medical screenings to confirm safety practices are effectively preventing occupational injury or illness. All costs associated with obtaining occupational health services are covered by NCSLPH.
Bachelor's degree in clinical laboratory science, medical technology, biology or chemistry from an appropriately accredited institution and three years of experience in a medical or health-related laboratory, environmental laboratory, or other scientific laboratory depending upon area of assignment;
an equivalent combination of education and experience.
Necessary Special Qualifications:
Must be capable of meeting the Federal CLIA 88 personnel requirements for a technical supervisor in a laboratory performing moderate complexity testing.