Sr. Clinical Laboratory QA 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 Clinical Laboratory Quality Assurance (QA) Specialist isresponsible for many quality aspects in the clinical laboratoryincluding developing, implementing, and maintaining a quality managementsystem, ensuring compliance with all regulatory requirements. TheClinical Laboratory QA Specialist will monitor effectiveness of thequality management system, identify, support, and facilitate continuousimprovement opportunities, and educate the workforce on applicableprocedures and regulations. Essential Duties Include, but are notlimited to, the following: Continuously monitor and maintain policiesand procedures to ensure the clinical laboratory meets respectivestandards and regulations, such as CAP, CLIA, New York, California,Maryland, and Florida. Develop laboratory-based metrics to measureefficacy of the quality system and provide visibility for managementoversight. Review and document nonconforming events, conductinvestigations, perform root cause analysis, and develop and implementcorrective and preventive actions. Provide assessment, quality input andguidance, investigational support, and resolution for end-user feedback;coordinate processes, reports, and documentation for escalations arisingfrom feedback. Review, investigate, evaluate, and maintain patientmedical records. Work with the privacy office and cross-departmentalstaff to provide guidance and awareness of health insurance portabilityand accountability act (HIPAA), protection of patient data, pertinentregulations and requirements, and relevant quality system policies andprocedures. Ensure quality system robustness and laboratory readinessthrough assisting with internal audits/investigations. Projectmanagement for process creations, improvement, and harmonization. Applyexceptional written and verbal communication skills. Strong attention todetail, organization, and record-keeping skills. Ability to collaborateacross functions and with both internal and external stakeholders.Strong leadership and decision-making... For full info followapplication link. We are an equal employment opportunity employer. Allqualified applicants will receive consideration for employment withoutregard to age, color, creed, disability, gender identity, nationalorigin, protected veteran status, race, religion, sex, sexualorientation, and any other status protected by applicable local, stateor federal law. Applicable portions of the Company's affirmative actionprogram are available to any applicant or employee for inspection uponrequest. APPLICATION INSTRUCTIONS: Apply Online:ipc.us/t/2AAB2E6B6ACC439A

Created: 2025-10-09