GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.

The Staff Quality Engineer will act as a key liaison for quality with reagent manufacturing operations and reagent QC. This individual will be responsible for process execution to Current Good Manufacturing Practices (cGMPs), GCP, ISO 13485, FDA 21 CFR part 820, and an understanding of CLIA, CAP, and New York State Licensures for LDTs. Support/complete mfg batch record review and reagent release, NCR Lifecycle, Material Management, Specification development, validation support, CAPA’s, and Quality Systems and Audit support. This position is required to be onsite at RTP (North Carolina).

You will:

• Quality SME for reagent manufacturing and reagent QC and provide QA support during manufacturing/laboratory operations, which may include shift coverage.
• Complete Reagent release to the Clinical Laboratory
• Provide QA support during manufacturing operations, which may include shift coverage.
• Ensure timely execution of technical assessments, review, Quality approvals and closure of Non-Conformances (NCR’s), CAPA’s and CC’s.
• Review/Write procedures as required for the QMS related to operations, equipment, material management etc.
• Develop, implement, and conduct a Quality operations training program (Receiving inspection, Sampling methodology, Reagent release, investigation., etc)
• Process Improvements and Validation support for RTP and MPK as required
• Oversee and monitor Quality processes to ensure operations are adequately defined and that GMPs are applied for the manufacture of reagents internally and at CMOs.
• Review and guide process validation and test method validation plans and protocols, completed protocols, and summary reports.
• Participate in risk assessment and / or Failure Mode and Effects Analysis activities for both process FMEAs.
• Define and implement, as appropriate, quality standards, systems, and metrics for commercial operations.
• Compile, organize, and present metrics for areas of responsibility to senior management.
• Participate in preparation for and execution of internal or external audits. Ensures audit observations are addressed appropriately and completed on schedule.
• Support Quality Management Reviews and periodic product reviews
• Participate in continuous improvement strategy which aligns to the business strategy and operational strategy while taking into account present operational realities.
• Participate in developing and setting operational KPI’s and drive improvements 

Your background and Qualifications will include:

• BA/BS and a minimum of 8 years in Quality Assurance.
• Chemistry, Engineering, or Biology background
• Minimum of 5-7 years in Quality Operations at an FDA-regulated medical device or pharmaceutical company.
• IVD experience (reagents and assays) preferred
• Method validation and process validation
• Proven experience in Change Control, CAPAs,
• Demonstrated success engaging teams and stakeholders for collaboration in advancing quality operations outcomes in business and quality leadership.
• Experience with contract manufacturing and/or testing organizations, including quality agreement negotiation.
• Ability to intake and process large quantities of information and subsequently make concise and timely decisions.
• Ability to communicate above and below level in a way that fosters positive relationship building.
• Proven knowledge of GxP regulations, quality systems, and regulatory guidance documents in the US and EU.
• Demonstrated flexibility and advancement within a fast-paced environment.
• Demonstrated project management skills.
• Ability to work effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view.
• Excellent attention to detail, project and time management skills, and the ability to manage multiple competing priorities.

GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, GRAIL has made the decision to require all U.S. employees receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.