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Exact Sciences · 2 hours ago

Clinical Laboratory Supervisor - MRD

Madison, WI

Full-time

Onsite

Mid, Senior Level

$67K/yr - $119K/yr

4+ years exp

Exact Sciences is dedicated to changing how the world prevents, detects, and guides treatment for cancer. The Clinical Laboratory Supervisor will oversee day-to-day laboratory operations, ensuring compliance with quality standards and regulations while supervising and developing laboratory staff. This role involves managing the quality management program and serving as a liaison to various internal and external entities.

BiotechnologyHealth DiagnosticsManufacturingMedical

No H1B

Responsibilities

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

Qualification

Molecular pathology methodsQuality ManagementLaboratory supervisionHigh complexity testingLaboratory Information SystemTrainingDevelopmentLeadershipTeam managementCommunication

Required

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

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