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Senior Process Engineer - Compliance #4968

GrailbioDurham🇺🇸United States

Quick overview

SeniorityMid Senior
Employment typeFull Time
Work modeOn Site
LocationDurham, United States
ComplianceDocument ManagementProcess Improvement

Job description

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.
We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.
GRAIL is headquartered in the Bay Area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.
For more information, please visit grail.com

The Senior Process Engineer leads complex investigations,  compliance related initiatives and supports document management processes. This role is primarily responsible for driving quality management system (QMS) activities across engineering, validation, clinical laboratory and operations, including change control management, SOP lifecycle oversight, nonconformance (NC) and CAPA metrics management, training compliance, and continuous process improvement. The Senior Process Engineer works across functions to design and implement process improvements, serve as a technical resource to peers and technicians, and ensure compliance with regulatory and quality requirements.

In addition, this role provides advanced technical expertise in high-complexity molecular diagnostic workflows supporting the Galleri® assay and collaborates cross-functionally to ensure operational excellence, regulatory readiness, and sustained compliance with applicable regulatory and accreditation requirements.

This position works full time onsite in Durham, NC.

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