Clinical Quality Specialist

Company Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening.

Job Description

The Quality Specialist plays an integral role on the Quality team and supports the company’s compliance activities with the FDA Quality System Regulation and ISO 13485 as well as CLIA, CAP, and applicable state requirements. The Quality Specialist works closely with a wide variety of departments to support quality activities and identify opportunities for continual improvement.  

Essential Duties and Responsibilities:

• Key responsibilities will include reviewing and formatting variety of types of documents.
• Independently facilitate routing of controlled documents and ensure document format and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality.
• Manage and maintain the archival of documents and records.
• Coordinate and assign training to individuals on procedures in the electronic Quality Management System.
• Provide training and support on the use of the electronic Quality Management System.
• Collaborate with various departments to drive process improvement initiatives.
• Create and maintain quality metrics required for management review and/or to report to senior management.
• Develop and maintain organized records that demonstrate compliance to all company processes, regulations, and the company’s QMS.
• Represent Quality at cross functional meetings.
• Support routine Quality processes such as document control, providing employee training, investigating non-conformances, and developing Quality metrics.
• Ensure that all policies, procedures, and records are reviewed and approved.
• Perform and document internal audits and make recommendations for corrective actions.
• Execute special projects as assigned.
• Managing multiple projects at one time, ideally related to development of regulated or process documents with the ability to deliver high quality documentation.
• Participate in independent and team projects as defined by the department supervisor.

Qualifications

• B.S. degree in a scientific discipline
• 1-3 years of quality experience in the Life Sciences Industry
• Experience in compliance with quality standards in a regulated Molecular laboratory 
• Experience with utilizing a Laboratory Information Management System is preferred
• Effective verbal and written communication skills and ability to share and receive information from all levels of the organization throughout various departments
• Ability to constructively challenge concerns and engage in transparent conversations
• Ability to work effectively in a team environment and build strong working relationships
• Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
• Ability to identify, analyze and solve problems with minimal direction and escalate concerns to management
• Proven attention to detail and accuracy
• Effective organizational skills
• High degree of initiative and self-motivation
• Drive for results and continual improvement – Ensure procedures and processes are in place that lead to the delivery of quality results and continually assess their effectiveness to drive continual improvement
• Experience with Microsoft Office suite and Internet for business use

Additional Information

Hybrid Work Model: At Guardant Health, we have defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.

For positions based in Palo Alto, CA or Redwood City, C