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Supervisor, Quality Systems

3 months ago

Kingston, United States OPKO Health, Inc. Full time

We are looking for a Northern Quality Supervisor Clinical Lab, 40 hours per week in our Kingston, Poughkeepsie & Margaretville, NY locations.


Schedule: Monday - Friday 8:00 am - 4:30 pm


JOB DESCRIPTION:

Under the directive of the Quality Manager, the Quality Supervisor is responsible for the oversight of the department's Quality Analysts, Quality Specialists 1, and Quality Specialists II, planning and coordinating all of the functions within the scope of Quality. This includes but is not limited to reviewing, interpreting and maintaining the Quality Control Program, arranging for and conducting internal quality audits, assisting with and reviewing Method/Instrument Validations, coordinating proficiency survey programs, writing and reviewing standard operating procedures, maintaining compliance with all regulatory standards to ensure that services are of the highest quality, recognizing results or problems, assisting Laboratory with performance improvement/quality management monitors, and ensuring the laboratory is adhering to all regulatory requirements. The Quality Systems Supervisor is expected to remain current with OSHA, CLIA, COLA, and CAP best practices.


DUTIES AND ACCOUNTABILITIES: - Duties may include but are not necessarily limited to the following:

  1. Reviewing, interpreting and maintaining the Quality Control Program
  2. Arranging for and conducting internal quality audits
  3. Assisting with and reviewing Method/Instrument Validations
  4. Oversee proficiency survey programs
  5. Reviewing standard operating procedures
  6. Maintaining compliance with all regulatory standards to ensure that services are of the highest quality
  7. Recognizing results or problems that require referral to the Quality Systems Manager
  8. Assisting clinical or GenPath supervisors with performance improvement/quality management monitors
  9. Training personnel and competency assessments
  10. Maintaining supplies
  11. Management of departmental projects
  12. Communicating with department administration and enforcing all corporate policies.
  13. Assure proper qualification of laboratory personnel (credentialing) according to CLIA, CAP, and NYS standards
  14. Serves as a quality resource for problem solving and process improvement to ensure accurate test performance and meets all quality goals.
  15. Investigates and documents non-conforming events, non-conforming products, and CAPAs as necessary. Makes recommendations for monitors and improvements.
  16. Monitors and ensures implementation of goals to meet established quality assurance, quality control, quality improvement plans, and turnaround time.
  17. Ensures compliance with regulatory agency standards through maintaining proper documentation, conducting audits, and ensuring proper corrective actions.
  18. Addresses internal and external complaints, proficiency failures and biases
  19. Resource in the planning of validation study proposals, with Laboratory Management, prior to validating and implementing new methods and technologies, initiating validation studies, troubleshooting during the validation process, and review of experiments prior to submission where applicable.
  20. Is involved in inspection readiness preparation and exercises including but not limited to: self-inspections, process improvement excises (i.e. risk assessments) and workflow analyses. Supports, implements, and ensures compliance with all department and company policies and procedures.
  21. Enforces safety requirements.
  22. May perform other responsibilities as mandated by Clinical Laboratory Improvement Amendments (CLIA) and any other pertinent local, state, or federal regulations.
  23. Reviews inspection reports by regulatory agencies (State, CMS, CAP, and COLA) with the appropriate personnel as necessary.
  24. Performs other assignments or projects as specified by the Manager/Director.

QUALIFICATIONS:

  1. Bachelor of Science degree in medical technology or related science.
  2. 6 years clinical laboratory or clinical quality compliance experience.
  3. 2 or more years of quality experience.
  4. 2 or more years of supervisory experience (preferred).
  5. ASCP or other national certification preferred.
  6. ASQ a plus.
  7. Working knowledge of tools, methods, and concepts of quality assurance.
  8. Prior auditing experience preferred.
  9. Solid knowledge of relevant regulatory standards (FDA a plus).
  10. Strong analytical skills and problem-solving abilities.
  11. Excellent communication and writing skills.
  12. Strong computer (Word, Excel, Outlook).
  13. Must have the following skills: attention to detail, analytical, time management, leadership, team-oriented, interpersonal communication-both written and verbal, computer and technical skills.
  14. Travel required (Domestic U.S.) 25%

PHYSICAL DEMANDS:

  1. Medium work of lifting up to 50 pounds and/or carrying objects weighing up to 25 pounds.
  2. Responsible for lifting, carrying, pushing, and pulling objects.

METHODS OF EVALUATION: Documented evaluations occur initially, at the end of six months and annually thereafter.

  1. Direct observation of work performance by Supervisor
  2. Observation of compliance with Safety Protocols
  3. Review of intermediate test results or worksheets, quality control records, and/or preventative maintenance records
  4. Monitor the recording and reporting of test results
  5. Direct observation of performance of instrument maintenance/function checks
  6. Assessment of test performance through testing of previously analyzed samples, internal blind, or external proficiency testing samples
  7. Assessment of problem-solving skills
  8. Supervisory delegated functions (as applicable)

WORKING CONDITIONS:

  1. Work requires contact with water (hand washing and cleaning), biohazardous body fluids, and hazardous chemicals.
  2. Work is varied in nature with sufficient noise and interruptions to cause distraction and stress.
  3. Work requires sitting, standing, and/or walking for periods of up to four hours.
  4. Work requires close attention to detail and accuracy.
  5. OSHA risk factor: Category 1

BioReference is an Equal Opportunity Employer