Exact Sciences Corporation

Clinical Laboratory Supervisor - Saturday - Tuesday, 8:00pm - 6:30am shift

Job Locations US-WI-Madison
Req No.
2020-5646
Category
Clinical Lab Operations
Type
Regular Full-Time

Summary of Major Responsibilities

The Supervisor, Clinical Laboratory directs the technical day-to-day laboratory operation, which includes the general technical supervision and development of laboratory staff, assures that quality standards are being met, provides technical expertise to the laboratory and as needed, serves as the liaison to various internal and external entities. The Supervisor, Clinical Laboratory oversees the Quality Management program in the laboratory and ensures that the laboratory and the laboratory staff is in compliance with all laws and regulations that are required by CLIA, CAP, OSHA and any other applicable legislative organizations.

 

The hours for this position are Saturday - Tuesday from 8:00pm - 6:30am.

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 staff, maintain a process for staffing, recruiting, training, evaluation of competency, and ongoing educational development.
  • Provide technical supervision of the laboratory and is accessible to the laboratory personnel to provide on-site, telephone, or electronic 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 ensures all training is performed as required.
  • Evaluate competency of all laboratory personnel.
  • Possess effective management abilities so as to supervise department staff and maintain budgets.
  • Verify the test procedures performed, and establish the laboratory’s test performance characteristics; including the precision and accuracy of each test and test system. This is accomplished by:          
    • Reviewing proficiency testing.
    • Reviewing corrected reports and incident reports.
    • Reviewing Quality Control at least on a monthly basis.
  • Review 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 aide of the technical staff, and ensure that remedial action is taken whenever test systems deviate from the laboratory’s performance standards.
  • Ensure that all patient results are not reported until corrective actions have been taken and that test systems are functioning properly.
  • 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.
    • 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) 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.
  • Supervise staff; including, but not limited to, organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance.
  • Communicate 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.
  • 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 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 microscopes, microtomes, blades, strainers, pipettes 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 Madison locations.

Qualifications

Minimum Qualifications

  • Bachelor’s degree in chemical, physical, biological, or clinical laboratory/medical technology science. 
  • 6+ years of experience to include high complexity testing in a clinical laboratory setting.
  • 2+ years in a role with progressively increasing responsibilities; such as quality and control, lead technologist, or technical specialist.
  • Possession of or ability to obtain ASCP certification within 6 months of hire and maintain throughout employment history.
  • 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.
  • 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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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.

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