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 the liaison from quality with the Clinical Laboratory Operations. This individual will be responsible for Current Good Manufacturing Practices (cGMPs), GCP, ISO 13485, FDA, CLIA, CAP, and New York State are implemented. Additional Support for Clinical Laboratory batch records, NCR’s, Process Validation support, CAPA’s and Quality Systems and Audit support. This position is required to be onsite at RTP (North Carolina).

You will:

• Be the Quality SME for Laboratory Operations and provide QA support during manufacturing / laboratory operations, which may include shift coverage.
• Ensure timely execution of technical assessments, review, Quality approvals and closure of Laboratory Non-Conformances (NCR’s), CAPA’s and CC’s.
• Review/Write procedures for the QMS related to Laboratory operations, testing equipment, material management etc.
• Develop, implement, and conduct a Quality operations training program (Laboratory investigation, retesting, etc)
• Clinical Laboratory Batch records reviews/approvals/changes
• Process Improvements and Validation support for RTP and MPK as required
• Backup support for existing QE’s
• Lead all aspects of and monitor Quality Laboratory processes to ensure operations are adequately defined and that GMPs are used.
• 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 Laboratory.
• Define and implement, as appropriate, quality standards, systems, and metrics for commercial laboratory operations.
• 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
• Support the development, implementation, and revision of corporate quality systems.
• 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 qualifications and background will include:

• BA/BS and a minimum of 8 years in Quality Assurance.
• Biology/Chemistry background
• Minimum of 5 years in Quality Operations at an FDA-regulated medical device or pharmaceutical company.
• IVD experience (reagents and assays)
• Method validation and process validation
• Proven experience in Change Control, CAPAs, and tech transfer.
• Demonstrated success engaging teams and partners 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.
• 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.