Principal Clinical Lab QC Specialist

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Position Overview

The Principal Clinical Lab Quality Control (QC) Specialist serves as a subject matter expert (SME) who drives quality control excellence across the clinical laboratory and shapes the long-term direction and success of the clinical lab QC program through strategic leadership. This position is primarily responsible for establishing, optimizing, and sustaining robust QC programs that ensure compliance, accuracy, and reproducibility of clinical test results. The position requires deep technical expertise, strong cross-functional collaboration, and a strong understanding of both manual and automated workflows across clinical laboratory systems.

Essential Duties

Include, but are not limited to, the following:

• Serve as a Technical SME in laboratory QC practices and regulations, with broad understanding of cross-functional dependencies.
• Lead the development and implementation of scalable QC programs aligned with clinical operational goals.
• Solve complex, high-impact problems that affect test reliability, turnaround time, and regulatory adherence.
• Apply advanced knowledge of regulatory requirements (e.g., CLIA, CAP, NYSDOH, FDA, ISO 15189) in QC program design and oversight.
• Design and validate QC metrics, processes and acceptance criteria across diverse platforms in accordance with regulatory requirements.
• Establish and maintain clinical laboratory QC documentation, training protocols, and training material.
• Recommend and execute improvements to QC strategy, assay performance monitoring, and reagent release criteria.
• Anticipate and interpret evolving regulatory and operational challenges. Develop and implement proactive quality improvement strategies.
• Provide recommendations on process optimization, risk mitigation, and audit readiness.
• Represent QC in collaborative projects with cross-functional team members and stakeholders.
• Act as an indirect leader and mentor for peers and team members, guiding troubleshooting, quality initiatives, and professional development.
• Lead cross-functional projects involving high complexity, such as validation, reagent qualification strategies, and QC process optimization.
• Investigate complex QC issues using root cause analysis, trend monitoring, and innovative thinking.
• Directly influence lab performance by building sustainable, scalable QC programs.
• Clearly communicate complex technical and regulatory topics across all levels including leadership, auditors and cross-functional stakeholders.
• 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.
• Stay informed of procedure updates and changes and ensure 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.
• Participate in continuing education, personal development, and staff meetings. Prepare and present continuing education programs for department personnel, as requested.
• Maintain open and effective communication with personnel in work team and with members of other teams throughout the laboratory.
• Interact with other healthcare workers to solve problems and interpret patient lab results within the framework of medical technology.
• 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.
• Ability and means to travel between Madison locations and/or lab locations in other states.
• Ability to support multiple tests.

Minimum Qualifications

• Bachelor's or Master's degree in Clinical Laboratory Science, Molecular Biology, Genetics 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.
• 10+ years of experience in laboratory QC or laboratory operations setting with at least 6 years in molecular diagnostics and/or NGS.
• 6+ years of experience in performing, reviewing, and understanding quality control metrics on a routine basis.
• Demonstrated experience with automated laboratory workflows and QC systems.
• Strong working knowledge of LIS/LIMS platforms and their role in QC data integrity and traceability.
• In-depth understanding of laboratory regulations (e.g., CLIA, CAP, FDA, ISO 15189) and high complexity testing requirements.
• Strong analytical, problem-solving, and strategic thinking skills.
• Proficiency in laboratory information systems (LIS) and quality management software.
• 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.
• 8+ years of experience with clinical lab validation, verification and QC program implementation.
• 8+ years of experience in a Quality Control related role.
• 10+ years of molecular diagnostic and/or NGS laboratory experience.

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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