Supervisor, Clinical Laboratory Quality Control

US-WI-Madison
Req No.
2017-1969
Category
Clinical Lab Operations
Type
Regular Full-Time

Summary of Major Responsibilities

The Supervisor, Clinical Laboratory Quality Control works with the Clinical Laboratory Manager to coordinate, develop and communicate the Quality Control and Quality Assurance programs of the clinical laboratory. This position works collaboratively with the Quality Assurance team to coordinate and ensure the proper execution of proficiency testing, non-conforming event tracking, including escalation, root cause analysis, risk assessments. This position collaborates with the technology transfer group to ensure all aspects of new tests and enhancements are appropriately executed. Additionally, they will work with all managers and supervisors to ensure workflow enhancements including IT, automation and employee suggestions are evaluated and adopted as appropriate. The position, as necessary, performs complex laboratory tests in the clinical laboratory to provide physicians with rapid and accurate laboratory test results.

Essential Duties and Responsibilities

Technical Skills:

 

  • Performs moderate, and/or highly complex analytic processes without direct supervision.  Uses routine and specialized automated and non-automated laboratory procedures and/or techniques for which he/she is qualified, trained, and demonstrates competency according to established lab section operating procedures.
  • Operates laboratory instruments and ensures proper functioning of laboratory equipment.
  • Troubleshoots instrument malfunction(s) and performs preventive and corrective maintenance and repairs on all laboratory equipment.
  • Completes required maintenance activities on equipment, recognizes and elevates potential issues to the team members responsible.
  • Maintains records and reviews documentation of all aspects of the clinical laboratory.
  • Performs quality control procedures as specified and maintains quality control records and documentation necessary to meet the standards of accrediting agencies.
  • Understands and assists in training employees, on an as needed basis.
  • Verifies accuracy, and enters data in the laboratory computer system, along with appropriate explanatory or interpretive information.  Meets all section turn-around times.
  • Validates acceptability of test results by review of quality control and all other test parameters.
  • Identifies the technical, instrumental and/or physiologic causes of unexpected test results and assists the Clinical Laboratory Supervisor in developing corrective action.
  • Evaluates and calculates quality control statistics to assess accuracy, reproducibility and validity of current laboratory methods.
  • Monitors quality assurance and assists in data collection and preparation of QA indicators.
  • Performs internal and external proficiency testing.  Handles proficiency-testing samples in the same manner as patient samples.
  • Assists the Clinical Laboratory Manager and Supervisors in developing and distributing proficiency samples, analysis, and reporting of testing results.
  • Meets work product output expectations. 
  • Responds to technical questions consistent with level of training.
  • Participates in continuing education and staff meetings.  Prepares and presents continuing education programs for department personnel as requested. 
  • Assists in verifying competency of new employees.
  • Instructs personnel in work team(s) on new methods and/or instruments.
  • Contributes to design, research, review and writing of laboratory manuals. 

Knowledge Base:

 

  • Complies with safety and hazard regulations as outlined in the Clinical Laboratory Safety Manual.
  • Recognizes unexpected results, errors and problems with patient tests and works collaboratively to resolve the problems.
  • Identifies technical, instrumental and/or physiologic causes of unexpected test results.  Assists the supervisor and Clinical Laboratory Supervisor in developing solutions to problems based on knowledge of biochemical theory/reactions, patient diagnosis and instrument performance.
  • Ensures quality and timeliness of patient test results by investigating problems involving specimen collection, result reporting, and turn-around time.  Interprets problems with specimens which meet the rejection criteria for unacceptable samples. 
  • Uses statistical methods to assess laboratory testing.
  • Observes principles of data security and patient confidentiality.  Maintains ethical standards in the performance of testing and in interactions with patients, co-workers and other health care professionals.
  • Resolves and documents resolution of all QC results which fail lab criteria and institutes corrective action.
  • Evaluates instrument/method failure and determines when back-up methods must be initiated.
  • Supervises laboratory personnel as assigned.
  • Implements changes as assigned in response to new technology and laboratory procedures.

Communication:

 

  • Maintains open and effective communication with personnel in work team, and with members of other teams throughout the laboratory. 
  • Demonstrates willingness to cooperate with team members and with cross-functional groups in the laboratory to accomplish timely and accurate testing.
  • Demonstrates professional demeanor, in personal appearance and behavior, in all work-related interactions inside and outside of the laboratory.

Qualifications

Mandatory Skills & Qualifications:

  • Appropriate certification from one of the nationally recognized certification agencies, i.e. ASCP or state licensure that has been determined to be equivalent.
  • Demonstrated ability to respond to stakeholder requests in a professional and timely manner
  • Exceptional written and verbal English communication skills and strong attention to detail
  • Detailed understanding of the laboratory information systems including Exact Sciences System Software

Necessary Education and Experience

  • S. / B.A. degree in Clinical Laboratory Science or Medical Technology or in the chemical or biological sciences. Must satisfy the education requirements of the applicable certifying agency, i.e. ASCP.
  • Minimum of 5 years moderate or high complexity testing experience
  • Experience formally or informally leading people or initiatives in a clinical laboratory setting

Physical Requirements & Working Conditions:

  • Ability to lift and move 20-40 pounds on an occasional basis (up to 25% of time).
  • Ability to stand, walk, bend and reach on a regular basis (standing ≈50% of time; sitting ≈50% of time).                
  • Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
  • Ability to listen and speak on the telephone and write simultaneously.
  • Ability to operate telephone system and computer keyboard and mouse.
  • Position requires work in normal laboratory environment.  Special uniform and personal protective equipment is required while working in the laboratory.

Exact Sciences is 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. The Company’s affirmative action program is available to any applicant or employee for inspection upon request.

 

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