POSITION SUMMARY

The Quality Systems Manager is responsible for all quality improvement/compliance related issues and is the resource person when there is a need for document review and compliance assessment. The incumbent works closely with lab supervisors to ensure that operating procedures and protocols are in compliance with NYS DOH, OSHA, Bloodborne Pathogen Exposure, Chemical Hygiene, and emergency responses.  The Quality Systems Manager establishes and maintains a routine documented schedule of quality control and quality assurance, including satisfying the external quality control procedures established by the College of American Pathology and CLIA, along with document review, communication, training, compliance assessment and ongoing compliance monitoring requirements under the laboratory quality management plan.

PRIMARY DUTIES

  1. Develops and maintains an effective quality management system.
  2. Develops, maintains, revises, and implements changes to quality and laboratory safety standard operating procedures/policies to ensure quality, safety, and compliance.
  3. Helps laboratory supervisors maintain and review preventive maintenance programs for instrumentation.
  4. Gathers appropriate data for reports; compiles quality control logs, workload counts and gives designated reports to the laboratory supervisor and/or Laboratory Director.
  5. Coordinates and reviews proficiency testing programs for participating regulatory agencies.
  6. Coordinates and monitors instrument and procedural troubleshooting activities.
  7. Monitors and assures laboratory employees are provided with sufficient continuing education exercises each year.
  8. Maintains and monitors compliance with regulatory agency guidelines such as New York State Department of Health (NYS DOH), College of American Pathologists (CAP), and Centers for Medicare & Medicaid (CMS, CLIA). Participates in on-site regulatory reviews as available.
  9. Conducts regular audits as determined by the Laboratory Director, CAP, and NYS DOH.
  10. Serves as a constant committee member of Quality Assurance Committee. Coordinates the monthly Quality Committee meetings and maintains pertinent meeting records
  11. Assists preparing job descriptions and participates in the interview and selection process of new personnel for pertinent positions.
  12. Offers suggestions for improvement in operations, recommends and implements staffing levels, reassignments and operational changes to enhance delivery of service.
  13. Assumes responsibility for the outcomes of assigned laboratory testing area.
  14. Leadership role in orientation, education, training and competency of new clinical laboratory personnel.
  15. Prepares and examines specimens using a variety of instruments, histologic and molecular diagnostic techniques.
  16. Sets up and works with laboratory equipment in order to test tissue, blood and blood parts for various indicators of clinical conditions.
  17. Reviews work of subordinate-level staff, providing technical oversight and ensuring quality results.
  18. Utilizes analysis software for QC monitoring, report interpretation and generation.
  19. Utilizes Laboratory Information System (LIS) and Clinical Laboratory Information Management System (C-LIMS) for tracking, documenting and reporting patient test results.
  20. Assists in the training and education of employees/students to explain and demonstrate testing procedures and standard operating procedures.
  21. Prepares and reviews standard operating procedures. Manages the controlled electronic document repository, SharePoint site of SOPs and Policies.
  22. Maintains established departmental policies and procedures, objectives, quality assurance programs, safety and compliance standards.
  23. Assists in the assignment and coordination of laboratory duties of staff.
  24. Maintains a safe and well-stocked work environment; validates reagents, instruments and procedures.
  25. Involved in relevant quality control and continuous quality improvement activities, the performance of calibration and maintenance procedures.
  26. Enhances professional growth and development by participating in educational programs, reading current literature and participating in in-service meetings and workshops.
  27. Prepares other written documentation as required by the profession and the department; maintains, distributes, analyzes and projects information for required records, reports and statistics as directed.
  28. Attends meetings as required.
  29. Performs other related duties as assigned or requested.

OTHER DESCRIPTIVE ELEMENTS

The Quality Systems Manager typically reports to the Laboratory Director, Assistant Laboratory Director, and Clinical Laboratory Supervisor.  The incumbent must have the education, experience and authority to discharge the responsibilities of the position and must have access to personnel at all levels of the laboratory organization as required.

RELATIONSHIP WITH OTHERS

The Quality Systems Manager has contact within the department and routine contact outside the department.

FUNCTIONAL RESPONSIBILITIES

  1. Must be familiar with a personal computer and the pertinent Laboratory Information Management System(s).
  2. Must have knowledge of molecular laboratory test procedures.
  3. Must demonstrate the ability to prioritize tests to be performed in emergency situations.
  4. Must possess a working knowledge of instrumentation/procedures and perform preventive maintenance and troubleshooting.
  5. Must have general knowledge of age-specific ranges/testing requirements and age-specific requirements for sample collection.

MACHINES, TOOLS AND EQUIPMENT USED

  1. Personal computer
  2. Laboratory Information System (LIS) and Clinical Laboratory Information Management System (CLIMS)
  3. Various laboratory equipment and analytic software tools

PHYSICAL DEMANDS

While performing the duties of this job, the Quality Systems Manager is frequently required to talk or hear and use hands or fingers to manipulate, touch or handle.  The incumbent is regularly required to stand, sit, and reach with hands or arms.  He/she is occasionally required to walk.  The incumbent is occasionally required to lift and/or move up to ten (10) pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth vision and the ability to adjust focus. The physical demands described here are not job requirements, but are representative of those demands that are typically expected of employees to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to successfully perform the essential functions.

WORKING CONDITIONS

The noise level in the work environment is usually moderate.

REQUIRED EDUCATION AND EXPERIENCE

  1. Doctorate degree in Biological Sciences or a related field and the equivalent of one (1) year of full-time experience in a CLIA certified laboratory subsequent to obtaining a Clinical Laboratory Technologist license issued by the New York State Education Department; or
  2. Master’s degree in Biological Sciences or a related field and the equivalent of four (4) years of full-time clinical laboratory experience including one (1) year of experience in a CLIA certified laboratory; the experience requirement must be met subsequent to obtaining a Clinical Laboratory Technologist license issued by the New York State Education Department; or
  3. Bachelor’s degree in Biological Sciences or a related field and the equivalent of six (6) years of full-time clinical laboratory experience including one (1) year of experience in a CLIA certified laboratory; the experience requirement must be met subsequent to obtaining a Clinical Laboratory Technologist license issued by the New York State Education Department.

NOTES: Required degrees must have been granted by an accredited college or university or one recognized by OmniSeq as following acceptable educational practices.