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Position Overview
The General Supervisor, Clinical Laboratory 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.
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 CLIA, 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, and courage, and set a clear vision to energize teams towards the future.
- Effectively manage, support, and guide your team, including, but not limited to delegating tasks and responsibilities, assess employee performance and provide helpful feedback and training opportunities.
- 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.
- Ability to work on a designated schedule.
- Ability to work nights and/or weekends.
- Ability to lift up to 40 pounds for approximately 25% of a typical working day.
- Ability to work seated for approximately 50% of a typical working day. Ability to work standing for approximately 50% of a typical working day.
- Ability to listen and speak on the telephone and write simultaneously.
- Ability to operate telephone system and computer keyboard and printer.
- Ability to comply with any applicable personal protective equipment requirements.
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 75% of a typical working day.
- Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
- Ability to use various types of laboratory equipment including pipettes, liquid handlers, analyzers, and other assigned instrumentation for extended periods of time.
- Ability to perform repetitious actions using lab tools.
- Ability to use near vision to view samples at close range.
- May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
- Ability and means to travel between Exact Sciences locations.
Minimum Qualifications
- Bachelor’s degree in chemical, biological, or clinical laboratory/medical technology science.
- 4+ years of experience to include high complexity testing (at least one of which is in molecular pathology methods) in a clinical laboratory setting.
- 2+ years in a role with progressively increasing responsibilities, such as quality control, lead technologist, or technical specialist.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
- Authorization to work in the United States without sponsorship.
Preferred Qualifications
- 1+ years of laboratory supervision experience.
- 6+ years of experience to include high complexity testing in a clinical laboratory setting.
- Appropriate certification from one of the nationally recognized certification agencies; i.e., ASCP or state licensure that has been determined to be equivalent.
- 1+ years of experience with Laboratory Information’s System (LIS) requirements and workflow needs.
- 1+ years of 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.
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Salary Range:
$69,000.00 - $122,000.00
The annual base salary shown is for this position located in US - WI - Madison on a full-time basis. In addition, this position is bonus eligible.
Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.
Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.
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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law.
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