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Supervisor, Clinical Laboratory Operations - Monday - ...

Exact Sciences Corporation - Baltimore, MD

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Job Description

Position OverviewThe Supervisor, Clinical Laboratory Operations, DNA Analytics directs the technical day-to-day laboratory operations, under the direction of the Director of Laboratory Operations (or designee); including, but not limited to, the general technical supervision and development of laboratory staff, assure quality standards are met, provide technical expertise to the laboratory, and serve as the liaison to various internal and external entities, as needed. The Supervisor, Clinical Laboratory Operations, DNA Analytics oversees the quality management program in the laboratory and ensures that thelaboratory staff follow all laws and regulations that are required by CLIA, CAP, OSHA, and any other applicable legislative organizations.Essential DutiesInclude, 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, but not limited to, applicable requirements and regulations such as CLIA, CAP, California, and New York (CLEP).Evaluate equipment and supply needs of the laboratory; including, but not limited to, work with the laboratory operations leadership to ensure expenses are within the departmental budget, assure proper ordering of supplies and equipment, monitor supply usage and variances, and review test volumes with laboratory operations leadership to ensure appropriate staffing to maintain established turn-around-times.Provide technical supervision of the laboratory and is accessible to laboratory personnel to provide on-site, telephone, or electronic consultation.The Laboratory or Medical Director has delegated the following technical responsibilities to the Laboratory Technical Supervisor: Verify test procedures are performed and establish the laboratory''s test performance characteristics; including, but not limited to, precision and accuracy of each test and test system. This is accomplished by reviewing the following: proficiency testing, corrected reports and incident reports, quality control, at least monthly, 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 aid of technical staff, and ensure that remedial action is taken whenever test systems deviate from the laboratory''s performance standards.Ensure all patient results are not reported until corrective actions have been taken and that test systems are functioning properly.Ensure enrollment and participation in proficiency testing.Participate in selection of test methodology.Identify training needs and ensure that all training is performed; including, but not limited to, sign technical training records and design training checklists.Evaluate competency of all testing personnel, with the help of qualified technical staff, and ensure that staff maintains competency to perform test procedures and report test results promptly, accurately, and proficiently. The procedures for evaluation of competency include, but are not limited to, observe routine patient test performance, monitor the recording and reporting of results, review intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance.Assess testing personnel test performance through testing previously analyzed specimens (quality assurance split samples) or external proficiency testing samples.Assess testing personnel problem solving skills.Evaluate and document the performance and competency of individuals six months after initial training. Evaluation must be done annually, unless method or instrumentation changes, in which case, before reporting patient results, the individual''s performance must be reevaluated.Supervise staff; including, but not limited to, organize and prioritize work, write/conduct performance reviews, train/develop, and manage work municate goals clearly to employees to ensure understanding and success in achieving them.Motivate and inspire employees to do their best work through coaching.Maintain morale and support employee engagement initiatives.Ability to act with an inclusion mindset and model these behaviors for the organization.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.Maintain regular and reliable attendance.Ability to work designated schedule.Ability to lift up to 20 pounds for approximately 5% 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 work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 80% 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 comply with any applicable personal protective equipment requirements.Ability to use various types of laboratory equipment; including microscopes, microtomes, blades, strainers, and pipettes for extended periods of time.May 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 locations.Minimum QualificationsQualified to complete competency assessment per CLIA Regulations by meeting one of the following criteria:Bachelor''s Degree in a Chemical, Physical, Biological, Clinical Laboratory science, or Medical Technology from an accredited institution, with 2+ years of lab experience/lab-education program experience in a lab providing moderate and/or high complexity testing or 1+ year performing high complexity testing.Associates Degree in a Laboratory science, Medical Technology, or equivalent education and training (specified below) and 2+ years lab experience/lab-education program experience in a lab providing high complexity testing.Equivalent Education and Training:60+ semester hours, or equivalent, from an accredited institution that, at a minimum, one of the following and 3 months documented laboratory training/education;24 semester hours of medical laboratory technology courses; or24 semester hours of science courses that include:6 semester hours of chemistry; and6 semester hours of biology; and12 semester hours of chemistry, biology, or medical laboratory technology in any combination6+ years of post-bachelor''s degree experience in a clinical laboratory setting; specifically in the creation of complex/boutique libraries that are then sequenced on an NGS platform.2+ years of experience in a clinical lab with doctoral director oversight and with progressively increasing responsibilities.2+ years of direct or indirect leadership experience.Demonstrated understanding in the areas of laboratory supervision; including, but not limited to, laboratory information system (LIS) requirements, workflow needs, and technical capabilities.Strong understanding of 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.Possession of or ability to obtain ASCP certification within 1 year of hire and maintain throughout employment in position.Demonstrated ability to perform the Essential Duties of the position with or without accommodation.Authorization to work in the United States without sponsorship.LI-RH1ClinicalLabIf you need any assistance seeking a job opportunity at Exact Sciences, or if you may require a reasonable accommodation with the application process, please call our Recruitment Coordinator at 608-535-8841 or email [Click Here to Email Your Resumé].We are 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. Applicable portions of the Company''s affirmative action program are available to any applicant or employee for inspection upon request.

Created: 2025-11-15

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