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Grail

Staff / Senior Process Engineer - Compliance #3509

Raleigh, NC Durham, NC
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Description
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.

***WE STRONGLY ENCOURAGE OUR VETERAN COMMUNITY TO APPLY***

The Staff/Sr Process Engineer - Compliance will plan, develop, improve, organize, and implement the Equipment lifecycle program according to multiple regulatory bodies.  They will also help improve our quality maturity in the engineering organization. This function will be responsible to reduce quality defects in our business and processes and provide practical GMP guidance and mentorship to our teams. The engineer will own and execute root-cause investigations, implement action plans for nonconformance's, internal/external audits and other compliance related matters. GRAIL’s processes are scaling fast and require a dynamic and detail oriented engineer to help deliver our revolutionary test to as many people as possible.

Expected schedule is on-site Monday to Friday.  This position may need to support weekends and holidays.  Alternative locations and work arrangements could be considered for the right individual.

Responsibilities;

  • Assure compliance with SOX, CLIA/CAP, FDA 21 CFR part 820, ISO 13485, IVDR requirements
  • Create and update work instructions, guidelines, verifications, and standard operating procedures (SOP)
  • Develop roadmaps and lead initiatives to ensure long term compliance sustainability
  • Leads CAPAs and associated quality investigations
  • Participate, be a role model, and adhere to GRAIL’s policies and guidelines
  • Provide training, support in the creation of new training, and transfer knowledge
  • Recommend and implement changes to ensure ongoing high-quality and efficient engineering operations procedures as part of the continuous improvement process
  • Supports audit readiness and on-site audits
  • Work closely with Quality and regulatory to implement and follow the required policies and procedures for the lifecycle of equipments
  • Anticipates and resolves conflict situations in a win - win outcome

Preferred qualifications;

  • 5+ years of related experience with a BS/BA or higher degree in Engineering or Life Sciences or equivalent
  • Experience executing within a computerized maintenance/calibration management system, product lifecycle managements systems, and quality management systems
  • Experience working in a clinical laboratory regulated environment
  • Knowledge of lean tools and root cause analysis methodologies
  • Strong background in GMP manufacturing
  • Project management skills
  • Ability to work in a matrix organization
  • High emotional intelligence with proven ability to set a course and bring his/her peers forward with them.
  • Excellent communication skills to work as a leader, provide internal customer support, and influence other departments and individuals
  • Excellent time management skills to support a fast paced working environment
  • Strong leadership skills with demonstrated ability to effectively work across teams and functions
  • Highly Preferred:
  • Graduate degree in an engineering or scientific discipline
  • Veeva experience
  • Experience with Laboratory Information Management Systems (LIMS) and Manufacturing Management Systems (MES)

  • Ability to travel up to 15% of the time
Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.

In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.

GRAIL is an Equal Employment 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. GRAIL maintains a drug-free workplace.
Grail
Grail
Biotechnology Health Care Health Diagnostics Medical Medical Device

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