Principal Clinical Lab QC Specialist

JOB REQUIREMENTS: Help us change lives At Exact Sciences, we'rehelpingchange how the world prevents, detects and guides treatment forcancer. We give patients and clinicians the clarity needed to makeconfident decisions when they matter most. Join our team to find apurpose-driven career, an inclusive culture, and robust benefits tosupport your life while you're working to help others. PositionOverview The Principal Clinical Lab Quality Control (QC) Specialistserves as a subject matter expert (SME) who drives quality controlexcellence across the clinical laboratory and shapes the long-termdirection and success of the clinical lab QC program through strategicleadership. This position is primarily responsible for establishing,optimizing, and sustaining robust QC programs that ensure compliance,accuracy, and reproducibility of clinical test results. The positionrequires deep technical expertise, strong cross-functionalcollaboration, and a strong understanding of both manual and automatedworkflows across clinical laboratory systems. Essential Duties Include,but are not limited to, the following: Serve as a Technical SME inlaboratory QC practices and regulations, with broad understanding ofcross-functional dependencies. Lead the development and implementationof scalable QC programs aligned with clinical operational goals. Solvecomplex, high-impact problems that affect test reliability, turnaroundtime, and regulatory adherence. Apply advanced knowledge of regulatoryrequirements (e.g., CLIA, CAP, NYSDOH, FDA, ISO 15189) in QC programdesign and oversight. Design and validate QC metrics, processes andacceptance criteria across diverse platforms in accordance withregulatory requirements. Establish and maintain clinical laboratory QCdocumentation, training protocols, and training material. Recommend andexecute improvements to QC strategy, assay performance monitoring, andreagent release criteria. Anticipate and interpret evolving regulatoryand operational challenges. Develop and implement proactive qualityimprovement strategies. Provide recommendations on process optimization,risk mitigation, and audit readiness. Represent QC in collaborativeprojects with cross-functional team members and stakeholders. Act as anindirect leader and mentor for peers and team members, guidingtroubleshooting, quality initiatives, and professional development. Leadcross-functional projects involving high complexity, such as... Forfull info follow application link. We are an equal employmentopportunity employer. All qualified applicants will receiveconsideration 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 protectedby applicable local, state or federal law. Applicable portions of theCompany's affirmative action program are available to any applicant oremployee for inspection upon request. APPLICATIONINSTRUCTIONS: Apply Online: ipc.us/t/B062F9B3569346BF

Created: 2025-10-04