Lab Quality Lead

VerilySan Bruno, CA
22d

About The Position

As a Lab Quality Lead at Verily, you will work with the organization to act as a champion of Quality Assurance activities for development and commercial laboratory services and projects. You will support the implementation and maintenance of quality programs, systems, and operations related to Good Laboratory Practices (GLP) and Good Clinical Laboratory Practices (GCLP). You will help develop phase-appropriate quality strategies during different phases of product development, from research to pre-clinical and clinical phases. You hold your work and teams to the highest quality standards and ensure that all corporate business requirements, regulations, and other standards are met as applicable. This is a hands-on role where you will apply intensive, self-directed and diversified knowledge of laboratory and quality principles for Verily’s programs and platforms.

Requirements

  • BA/BS degree in science, life sciences, related technical field, or equivalent practical experience.
  • 5+ years of experience in R&D Quality or product development in the pharmaceutical, biotech, life sciences, or clinical research industries.
  • Experience with Laboratory Quality Management Systems (QMS) and LIMS
  • Knowledge of ISO/IEC 17025 – Testing and Calibration Laboratory Requirements
  • Experience in project management, training, and working collaboratively with product development teams.

Nice To Haves

  • Experience with digital health.
  • Expertise in GLP or GCLP highly preferred
  • Experience working with novel technologies in a lean, fast-paced and highly innovative environment.
  • Demonstrated ability to implement and improve QMS processes using industry best practices, tools and agile/scrum/iterative methodology.
  • Excellent organizational, interpersonal and verbal and written communication skills, with the ability to deliver quality outputs under minimal supervision.

Responsibilities

  • Guide and train laboratory personnel in adhering to GLP/GCLP, when applicable.
  • Review and approve laboratory procedures, changes to LIMS, and data.
  • Facilitate phase-appropriate GxP compliance for test method development and validation; sample handling, processing and storage; equipment calibration and maintenance; data integrity; and documentation.
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