Laboratory Corporation of America Quality Manager-Regional in Burlington, North Carolina
- SUMMARY Provides, along with 2 other quality managers, quality oversight for patient and clinical trials testing services conducted in the CET & ADRL laboratory. Participates in developing, implementing, and maintaining the laboratory's Quality Management System. Promotes a culture of quality throughout the laboratory and collaborates with site management staff to ensure regulatory and accreditation compliance and overall quality of services. SCOPE OF SUPERVISION This position reports to the AVP, EBU Quality Director and receives minimal direct supervision. RESPONSIBILITIES:
Participates in all aspects of the Quality Management System including: management review, internal audits, supplier assessment, nonconformances and deviations, and corrective/preventive actions. Collaborates with operations management on documents and records management and customer complaints.
Reviews, interprets, and effectively communicates regulatory and accreditation requirements and their impact on the laboratory.
Interfaces with regulatory and accreditation agencies as necessary and ensures the laboratory maintains as current its federal, state, and local licenses and accreditations.
Prepares the laboratory for and participates in external quality audits. Provides summaries of external audits to management staff. Writes and/or reviews responses to external citations.
Prepares the monthly quality report with analysis of various issues. Coordinates and conducts regular Management Review Meetings.
Maintains a process for investigating nonconformities, determining root cause(s), implementing corrective action, and evaluating effectiveness.
Maintains processes for controlling changes to processes and evaluating and mitigating risks.
Ensures the laboratory is properly enrolled in proficiency testing appropriate for the complexity of tests performed. Oversees the coordination of laboratory PT activities.
Performs audits of vendors and subcontractors s needed.
Writes and revises SOPs pertaining directly to the quality management system.
Provides training for staff throughout the laboratory in quality management principles.
Escalates quality concerns as appropriate to the National Office of Quality.
Actively participates in planning, projects, and improvement teams to support the laboratory, as appropriate.
Administrative: Ability to relate professionally with people, analytical abilities, compose letters/memoranda, coordinate projects and events, motivate others, organizational skills, research information, time management, train employees, use computerized databases, effective written and verbal communications.
Machine: Calculator, personal computer.
Physical Demands: Speech clarity; repetitive motions -- making frequent movements with fingers and hands; standing -- remaining on one's feet in an upright position; sitting -- remaining in the normal seated position; use of hands -- seizing, holding, grasping, or otherwise working with hands.
Working Conditions: Possible exposure to infection from disease-bearing specimens; regularly exposed to the risk of blood-borne diseases; must comply with applicable safety procedures .
Vision Requirements: Far acuity -- ability to see clearly at 20 feet or more; near acuity -- ability to see clearly at 20 inches or less; depth perception -- ability to judge distance and space relationships; color vision -- ability to distinguish and identify different colors.
License/Certification/Education: BA or BS degree in medical technology, biology, chemistry or related field with 5-7 years quality related experience that includes internal auditing, nonconforming events, CAPA systems, writing and reviewing SOPs, trending and analyzing data. Working knowledge of CLIA, NYS, and other applicable federal and state regulatory requirements, ISO, and GxPs is highly desirable.
*This job description reflects the essential functions of the position and excludes those that may be incidental to the performance of the job. In no way is it stated or implied that the principle functions are the only duties to be performed. Employees will be required to follow any other job-related instructions and to perform any other job related duties requested by their supervisor.
Normally a B.A./B.S. in Biology w/4-5 years of Clinical Laboratory experience, including 5 years in Quality Assurance and/or Quality Management.
At least 2 years of Supervisory experience
Knowledge of FDA regulations
Monday - Friday 8a-5p
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.