Clinical Laboratory Supervisor

4 weeks ago

Madison, United States Exact Sciences Corporation Full time

**Help us change lives**

At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.

**Position Overview**

This role will be performed during nights and/or weekend hours. The General Supervisor, Clinical Laboratory - Off-Shift directs the day-to-day laboratory operations, under the direction of the Director of Laboratory Operations (or designee); including, but not limited to, the general supervision and development of laboratory staff, assuring quality standards are met, providing technical expertise to the laboratory, and serving as the liaison to various internal and external entities, as needed. The General Supervisor, Clinical Laboratory oversees the quality management program in the laboratory and ensures that the laboratory and laboratory staff follow all laws and regulations that are required by CLIA, CAP, OSHA, and any other applicable legislative organizations. This role meets the CAP requirements for General Supervisor.

**Location**: 145 E. Badger Road & 650 Forward Drive

**Essential Duties**

Include, but are not limited to, the following:

- Identify and understand regulatory requirements to ensure the laboratory is compliant with all applicable laws and regulations pertinent to the management of the laboratory, including applicable LIA, CAP and other requirements and regulations.
- In conjunction with support staff, maintain a process for staffing, recruiting, training, evaluation of competency, and ongoing educational development.
- Provide supervision to the laboratory and is accessible to the laboratory personnel to provide on-site consultation.
- Evaluate equipment and supply needs of the laboratory.
- Work with laboratory leadership to ensure expenses are within the departmental budget.
- Assure proper ordering of supplies and equipment.
- Monitor supply usage and variances.
- Review test volumes with the laboratory leadership to ensure appropriate staffing to maintain established turn-around-times.
- Verify the test procedures performed, and along with laboratory leadership establish 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 ensure 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 ensure all training is performed as required.
- Evaluate competency of all laboratory personnel.
- Possess effective management abilities to supervise department staff and maintain budgets.
- Verify the test procedures performed. This is accomplished by:

- Reviewing proficiency testing.
- Reviewing corrected reports and incident reports.
- Reviewing Quality Control at least monthly.
- 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.
- 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.
- Monitor the recording and reporting of results.
- Review intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance.
- Assess test performance through testing previously analyzed specimens (QA Split Samples, contrived specimens) or external proficiency testing samples.
- Assess problem solving skills.
- Evaluate and document 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.
- Consistent demonstration of exceptional leadership qualities, including but not limited to the ability to attract and retain the best team, foster a culture of high performance, lead with integrity, humility, accountability,

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