Supervisor, Clinical Lab Operations
Summary of Major Responsibilities
The Clinical Laboratory Operations Supervisor of Night Operations directs the nightly operations of the laboratory under the direction of the Senior Director of Laboratory Operations (or designee) which includes the general and technical supervision of the Exact Sciences operations and staff including the Pre-Processing, Technical laboratory, Customer Care Center and additional employees working on the overnight shift. This position assists in the development of staff, assures quality standards are met, provides technical expertise to the laboratory and as needed, and serves as the liaison to various internal and external entities. The Clinical Laboratory Operations Supervisor oversees the overnight shift ensuring that the laboratory and the laboratory staff are in compliance with all laws and regulations that are required by CLIA, CAP, OSHA, NY and any other applicable legislative or industry based organizations.
This position will work a shift of 8:00 PM - 6:30 AM, Saturday - Tuesday.
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 assists with 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 and general oversight of the ES 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:
- 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 and non-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
- Identifies training needs and ensures all training is performed as required
- In coordination with supervisors and teaching specialists, evaluates competency of laboratory personnel as needed
- Possess effective management abilities so as to supervise department staff and maintain budgets
- Receives training to assist the Customer Care Center and Specimen Processing employees to troubleshoot and resolve problems.
- Responsible for immediate troubleshooting of problems and determining when on call support is called
- Responsible for general safety and security of the building and staff
- Review inventory and perform cycle counts as necessary
- Assist with pilot studies, workflow analysis and provides input and suggestions to management to increase throughput and efficiency
- Assist as needed with facility and security reviews, audits and reporting
- Assist with sample management
- Assists all other departments with troubleshooting, analysis and customer care problems
Clinical Laboratory Technical Supervisory Responsibilities:
Clinical Laboratory Technical Supervisor must be accessible to the laboratory to provide on-site, telephone, or electronic consultation.
- 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
Mandatory Skills & Qualifications:
- 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 including 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.
Necessary Education & Experience:
- Bachelor’s Degree in chemical, physical, biological or clinical laboratory/medical technology science. ASCP certification required.
- Minimum of four years of post-bachelor’s degree experience with high complexity testing in a clinical laboratory setting with two years in a role with progressively increasing responsibilities such as quality and control, lead technologist, or technical specialist.
- Ability to work collaboratively with teams and supervisors throughout the laboratory
- Ability to make critical decisions in a timely manner
- Ability to assist facilities, Service and Support, EH&S, and outside responders when necessary.
Physical Requirements & Working Conditions:
- 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 and 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 lab work and performing multiple tasks simultaneously. Also dealing with the management pressures on a daily basis.
Exact Sciences is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. The Company’s affirmative action program is available to any applicant or employee for inspection upon request.
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