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Senior Quality Engineer, Reagent Manufacturing

Organization
GRAIL
Job Location
1525 O'BRIEN DRIVE
Menlo Park, CA 94025
United States
Job Description

The Senior Quality Engineer, Manufacturing plays an integral role in supporting Quality activities related to reagent manufacturing in accordance with FDA, ISO, and cGMP regulations. The Sr. Quality Engineer, Manufacturing also supports the company’s quality system activities that comply with the FDA’s Quality System Regulation, ISO 13485, cGMP as well as CLIA, CAP, and applicable state requirements.

You Will:

  • Primary point of contact for all quality activities related to the GRAIL’s Reagent manufacturing process and related process development activities. This includes providing guidance for Production and Process Controls, Risk Analysis, and decisions on process validation activities to ensure continued compliance with internal procedures and applicable regulations.
  • Provides technical leadership and “Design for Manufacturing” input to cross-functional teams.
  • Provides guidance to cross-functional teams responsible for implementation of process changes and improvements, including change control process.
  • Responsible for reviewing manufacturing records and disposition of material, as required.
  • Provides guidance on Good Manufacturing Practices (GMP) and creation of manufacturing documentation.
  • Provides guidance on sample sizes and statistical methodologies relevant to manufacturing.
  • Supports transition of the manufacturing process from design to production and ensuring that all design transfer activities are completed prior to product launches.
  • Support processes such as CAPA, nonconformances, training, and developing Quality metrics.
  • Identifies opportunities for continual improvement and works with management and team members to successfully address these opportunities.
  • Report and document all concerns of test quality and/or safety as applicable.
  • Performs other related duties and responsibilities as assigned by the Quality Functional Leader.
Requirements

Your Background Should Include

  • B.S. degree in Biology, Molecular Biology, BioMedical Eng., Chemistry, Mechanical Eng or a related scientific discipline
  • 5+ years of quality experience in a FDA/ISO regulated environment.
  • Certified Quality Engineer (CQE) preferred.
  • Experience in reagent manufacturing and process validation activities.
  • Experience in molecular biology products or molecular diagnostic products.
  • Knowledge of applying statistical analysis for process control, and design of experiments.
  • Excellent  knowledge of Risk Management discipline and must be able to apply quality principles (GMPs, 21 CFR 820, ISO 14971:2012, IEC 60601, ISO 13485) to Design Controls. GCLP or GCP experience preferred.
  • Excellent team player with demonstrated track record.
  • Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced environment.
  • Excellent problem-solving and analytical skills.
  • Effective communication and interpersonal skills.
About Our Organization

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 located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com

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