The Clinical Laboratory Technical Supervisor directs the technical day-to-day laboratory operation under the direction of the Director of Laboratory Operations (or designee) which includes the general technical supervision and development of laboratory staff, assures that quality standards are being met, provides technical expertise to the laboratory and as needed, serves as the liaison to various internal and external entities. The Clinical Laboratory Technical Supervisor oversees the Quality Management program in the laboratory and ensures that the laboratory and the laboratory staff is in compliance with all laws and regulations that are required by CLIA, CAP, OSHA and any other applicable legislative organizations.
The hours for this position are Tuesday - Friday from 8:00pm - 6:30am.
Essential Duties and Responsibilities
Identify and understand regulatory requirements to ensure the laboratory is in compliance with all applicable laws and regulations pertinent to the management of the laboratory, including applicable CLIA, CAP and other requirements and regulations such as California and New York (CLEP) laboratory programs.
In conjunction with support staff, maintains a process for staffing, recruiting, training, evaluation of competency and ongoing educational development.
Evaluate equipment and supply needs of the laboratory:
Works with the Director of Laboratory Operations (or designee) ensure expenses are within the departmental budget.
Assure proper ordering of supplies and equipment.
Monitor supply usage and variances.
Review test volumes with the Director of Laboratory Operations (or designee) to ensure appropriate staffing to maintain established turn-around-times.
Provide technical supervision of the laboratory and is accessible to the laboratory personnel to provide on-site, telephone or electronic consultation.
The Laboratory or Medical Director has delegated the following technical responsibilities to the Clinical Laboratory Technical Supervisor :
Verify the test procedures performed, and along with the Laboratory or Medical Director and Director of Laboratory Operations (or designee) establishes the laboratory’s test performance characteristics, including precision and accuracy of each test and test system.
Ensure that the quality management program is maintained by following parameters for acceptable performance for the pre-analytical, analytical and post-analytical testing processes.
Resolve all technical problems with the aid of the technical staff and ensures that remedial action is taken whenever a test deviates from the laboratory’s performance standards.
Ensure that all patient results are not reported until corrective actions have been taken and the systems are functioning properly.
Identify training needs and ensures all training is performed as required.
Evaluate competency of all laboratory personnel.
Possess effective management abilities so as to supervise department staff and maintain budgets.
The Clinical Laboratory Technical Supervisor must be accessible to the laboratory to provide on-site, telephone, or electronic consultation.
The Laboratory Technical Supervisor (as delegated by the Laboratory or Medical Laboratory Director) is responsible for:
Verifying the test procedures performed, and establishing the laboratory’s test performance characteristics, including the precision and accuracy of each test and test system. This is accomplished by:
Reviewing proficiency testing.
Reviewing corrected reports and incident reports.
Reviewing Quality Control at least on a monthly basis.
Reviewing and approve all procedures annually and any minor changes as they occur.
Ensure that the quality control program is maintained by following parameters for acceptable limits and levels are maintained throughout the entire testing process from initial receipt of specimen to reporting results.
Resolve all technical problems with the aide of the technical staff and ensuring that remedial action is taken whenever test systems deviate from the laboratory’s performance standards.
Ensure that all patient results are not reported until corrective actions have been taken and that test systems are functioning properly.
Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
Support and comply with the company’s Quality Management System policies and procedures.
Regular and reliable attendance.
Identify training needs and ensure that all training is performed:
Sign technical training records.
Design training checklists.
Evaluate competency of all testing personnel with the help of technical staff, and ensure that the staff maintains their competency to perform test procedures and report test results promptly, accurately, and proficiently. The procedures for evaluation of the competency of the staff must include:
Directly observing routine patient test performance, including patient preparation, if applicable specimen handling, processing and testing.
Monitoring the recording and reporting of results.
Reviewing intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance.
Assessing test performance through testing previously analyzed specimens (QA Split Samples) or external proficiency testing samples.
Assessing problem solving skills.
Evaluating and documenting the performance and competency of individuals six months after initial employment. Thereafter, evaluations must be done annually unless method or instrumentation changes; in which case, before reporting patient results, the individual’s performance must be reevaluated.
Ability to lift and move 20-40 pounds on an occasional basis (up to 5% of time).
Ability to stand, walk, bend and reach on a regular basis (standing ~50% of time; sitting ~50% of time).
Ability to listen and speak on the telephone and write simultaneously.
Ability to operate telephone system and computer keyboard and printer.
Position requires work in normal laboratory environment. Special uniform and personal protective equipment is required while working in the laboratory.
Visual, Hearing, Dexterity & Mental Demands
Vision: Adequate to perform the essential functions of the job such as read and perform laboratory tests.
Hearing: Adequate to perform the essential functions of the job such as hear timers go off, etc.
Speaking: Adequate to perform the essential functions of the job such as communicating with staff, patients, colleagues and providers.
Dexterity: Adequate to perform the essential functions of the job along with computer work.
Mental Demands: Adequate to perform the essential functions of the job such as the stress of reporting STAT lab work and performing multiple lab tests simultaneously. Also dealing with the management pressures on a daily basis.
Bachelor’s degree in Chemical, Physical, Biological or Clinical Laboratory/Medical Technology Science.
6+ years of post-Bachelor’s degree experience with high complexity testing in a clinical laboratory setting.
2+ years in a role with progressively increasing responsibilities such as quality and control, lead technologist, or technical specialist.
ASCP certification required.
Proven experience in the areas of laboratory supervision, Laboratory Information’s System (LIS) requirements and workflow needs and technical capabilities listed under the Essential Functions section of this document.
Experience working with Quality Management
Strong knowledge of all laws and regulations that are required by CLIA, CAP, OSHA, New York and other related legislative and/or state health departments and organizations.
Authorization to work in the United States without sponsorship.
Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
Internal Number: 2020-5485
About Exact Sciences
Exact Sciences is committed to helping win the war on cancer through early detection.