GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured.
GRAIL is using the power of high-intensity 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 and commercialize pioneering products for the early detection of cancer.
We are seeking passionate and talented individuals to join us in realizing our mission, which has the potential to alleviate the global burden of cancer.
In search of the right opportunity for you? Apply to GRAIL to be considered for future roles!
Supervisor, Quality Control (Reagents)
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. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.
GRAIL is seeking a Quality Control Supervisor for the LabOps Manufacturing Sciences and Technology team (MSAT), who will be primarily responsible for materials QC and associated tasks. The ideal candidate is a detail-oriented, active team player with experience in NGS assays and assay components. The candidate will be expected to partner with many functions of our organization - Automation, Product Development, LIMS, Quality, and Clinical Lab - to identify systems limitations, implement process improvements, write documentation, and be instrumental in the implementation and operation of an internal QC system.
- Focus on the Quality Control arm of the various Manufacturing Sciences and Technology team goals. This role includes monitoring the manufacturing of assay materials, coordinating material readiness timing with Supply Chain, ensuring Manufacturing quality control has passed, materials released into the LIMS system and general inventory, and supporting root cause analysis for materials failing QC.
- Lead the Material Review Board to disposition non-conforming materials.
- Execute flawlessly on manual, high complexity, Functional Tests on a biweekly cadence.
- Coordinate material transfers to the Clinical Lab for final material release testing.
- Document existing processes and review and maintain existing QC documentation.
- Investigate potential quality issues (both internal and external) and work with Quality to resolve Corrective and Preventive Actions (CAPA).
- Work cross-functionally to coordinate special projects and programs overseeing the logistics and implementation of special and/or large orders and inventory transfer requests.
- Uphold QC activity compliance with current Quality Systems including, but not limited to CLIA, CAP, and FDA regulatory guidelines.
- Become an expert in the materials used in the current production assays.
Your Background Should Include:
- B.S required, advanced degree strongly preferred in a relevant area.
- 1+ years of experience in Next Generation Sequencing assays and workflows.
- Experience with Automated sample preparation workflows.
- Experience developing and executing QC test workflows.
- Proficient with basic molecular biology laboratory techniques (e.g. pipetting, SPRI, PCR, qPCR) and nucleic acids extraction techniques and quantification (e.g., Nanodrop, Bioanalyzer, Fragment Analyzer, ddPCR).
- Excellent teamwork and collaboration skills.
- Ability to multi-task as needed in a start-up environment.
- Outstanding written and verbal communication skills.
- Independent, innovative, and creative thinker.
- General computer skills and proficiency in GSuite.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.