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Supervisor, Clinical Lab Quality Control
4 months ago
**Help us change lives**
At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.
**Position Overview**
The Supervisor, Clinical Laboratory Quality Control works with the Quality Control, Quality Assurance, and Clinical Laboratory Leaders to coordinate, develop, and communicate the Quality Control and Quality Assurance programs of the clinical laboratory. The Supervisor, Clinical Laboratory Quality Control directs day to day quality control, monitors assay validity, 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 appropriate groups and stakeholders 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 Supervisor, Clinical Laboratory Quality Control is responsible for career development, mentoring and coaching of QC Team members.
**Essential Duties**
Include, but are not limited to, the following:
- 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 assay malfunction based on quality control metrics.
- Upkeeps the laboratory’s inventory management system necessary to meet the standards of accrediting agencies and laboratory’s needs to maintain TAT.
- 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.
- Assists in laboratory inspection readiness.
- 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.
- Validates acceptability of test results by review of quality control and all other test parameters, including instrument performance qualifications.
- 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 proficiency testing, as necessary. Handles proficiency-testing samples in the same manner as patient samples.
- Assists the Manager, Clinical Laboratory Quality and Process Improvements Manager in distributing proficiency samples, analysis, troubleshooting, and reporting of testing results.
- Meets work product output expectations.
- Responds to technical questions as necessary.
- Participates in continuing education and staff meetings. Prepares and presents continuing education programs for department personnel as requested.
- Assists in verifying competency of new and current employees.
- Instructs personnel in work team(s) on new methods and/or instruments.
- Contributes to design, research, review and writing of laboratory manuals.
- Contributes to design, research, review and writing of validations and verifications.
- 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 t
