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Clinical Laboratory Quality Control Lead

Exact Sciences
Baltimore County, MD
Closing date
Aug 8, 2022

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Position Overview

The Clinical Laboratory Quality Control Lead provides leadership services within the quality control team, and within the clinical laboratory areas. This position is primarily responsible for assisting the Supervisor, Clinical Laboratory Quality Control in scheduling, coordinating, and elevating any noted issues to leadership of required quality control activities in the laboratory. The Clinical Laboratory Quality Control Lead works directly with the Quality Control Supervisor to anticipate and resolve issues related to completing required quality control sample processing, and timely resolution of any detected issues as well as staffing, scheduling, and throughput issues.

The shift for this role is Monday-Friday, 2PM to 10:30PM.

Essential Duties

Include but are not limited to the following:

* Understand, perform, and accurately document all required quality control samples to be run during a given testing period (daily, weekly, monthly, annually).

* Understand and assist in the technical nature of the position, if necessary, while working with the Quality Control Supervisor, Lab Operations Supervisor, Tech Transfer, and R&D.

* Prepare specimens for analysis and determines acceptability of samples within guidelines without direct supervision.

* Ensure quality and timeliness of patient test results by recognizing, investigating, and interpreting problems involving specimen collection, result reporting, abnormal or unexpected test results and turn-around time.

* Use routine and specialized automated and non-automated, moderate and/or highly complex laboratory procedures and/or techniques for which they are qualified and trained and demonstrates competency according to established lab section operating procedures without direct supervision.

* Understand NYSDOH, CLIA and CAP requirements of quality control samples, proficiency testing samples, and other special control measures.

* Assists Quality Control leadership in planning, writing, and executing of various laboratory procedures, verifications, and validations relating to laboratory tests.

* Understands and utilizes quality tools such as root cause analysis, five whys, fishbone diagrams, scatter diagrams, pareto charts and SBARs.

* Understands and utilizes statistical analysis methods.

* Comply with, understand, maintain, and enforce safety and hazard regulations as outlined in the Clinical Laboratory Safety Manual.

* Observe principles of data security and patient confidentiality.

* Maintain ethical standards in the performance of testing and in interactions with patients, co-workers, and other health care professionals.

* Contribute and provide constructive feedback for design, research, review and writing of laboratory policies and procedures.

* Informed of procedure updates and changes and ensures employees demonstrate knowledge and competency regarding changes.

* Provide information and/or instruction to clients, new employees, medical students, residents, peers, and the public, as requested and where appropriate.

* Maintain adequate inventory of laboratory reagents and supplies.

* Assist with scheduling, tracking, resulting, and inventory management of all quality control, and other special non-patient samples.

* Responsible for tracking and scheduling reagent lot changeover.

* Participate in continuing education, personal development, and staff meetings; prepares and presents continuing education programs for department personnel, as requested.

* In coordination with the Training department, assists in training of new employees and implements and assists in training employees on changes as assigned in response to new technology and laboratory procedures.

* Maintain open and effective communication with personnel in work team, and with members of other teams throughout the laboratory.

* Provide feedback to the Technical Supervisor for employee performance reviews.

* Interact with other healthcare workers to solve problems and interprets patient lab results within the framework of medical technology.

* Conduct regular check-in meetings with members of the team along with the Supervisor, Clinical Laboratory Quality Control.

* Ability to respond to stakeholder requests in a professional and timely manner.

* Exceptional written and verbal English communication skills.

* Strong attention to detail.

* Demonstrate professional demeanor, in personal appearance and behavior, in all work-related interactions inside and outside of the laboratory.

* Demonstrate adaptability by embracing changes in the laboratory with a positive attitude.

* Ability to comply with any applicable personal protective equipment requirements.

* 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 nights and/or weekends as needed.

* Ability to lift and move up to 40 pounds for approximately 25% of a typical working day.

* Ability to walk, bend and reach for up to 100% 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 grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.

* Ability to hear timer alarms.

* 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.

* Manage reporting STAT lab work and perform multiple lab tests simultaneously.

* Ability to support multiple tests.

Minimum Qualifications

* Bachelor's degree in Clinical Laboratory Science or Medical Technology or in the chemical or biological sciences which includes a minimum of 6 chemistry credits, 6 biology credits and a combined total of 24 credits in chemistry and biology.

* ASCP certification eligible to obtain within 1 year.

* 4+ years of experience in a laboratory setting.

* 1+ years of experience in performing, reviewing, and understanding quality control on a routine basis.

* Authorization to work in the United States without sponsorship.

* Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

* Appropriate certification from one of the nationally recognized certification agencies, i.e., ASCP or state licensure that has been determined to be equivalent.

* 2+ years of relevant experience within the Exact Sciences Technical Laboratory.

* 2+ years of experience in a Quality Control related role.

* 1+ years of molecular diagnostic laboratory experience.


If 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

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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