Company Description|Job Description
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 & GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence & early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers.
Essential Duties & Responsibilities:
- Support routine Quality processes such as document control, providing employee training, investigating non-conformances, & developing Quality metrics
- Provide day to day quality support for the clinical laboratory & manufacturing activities
- Collaborate with various departments to drive process improvement initiatives
- Create & maintain quality metrics required for management review and/or to report to senior management
- Provide Quality Assurance (QA) oversight for the laboratory & represent work with cross functional teams to resolve discrepancies & drive to closure.
- Develop & maintain organized records that demonstrate compliance to all company processes, regulations, & the company's QMS
- Represent Quality at cross functional meetings
- Ensure that all policies, procedures, & records are reviewed & approved
- Perform & document internal audits & make recommendations for corrective actions
- Assist with validation submissions & responses for state agencies
- Execute special projects as assigned
- Report & document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable.
- 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 & written communication skills & ability to share & receive information from all levels of the organization throughout various departments
- Ability to constructively challenge concerns & engage in transparent conversations
- Ability to work effectively in a team environment & build strong working relationships
- Ability to successfully balance & prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
- Ability to identify, analyze & solve problems with minimal direction & escalate concerns to management
- Proven attention to detail & accuracy
- Effective organizational skills
- High degree of initiative & self-motivation
- Drive for results & continual improvement - Ensure procedures & processes are in place that lead to the delivery of quality results & continually assess their effectiveness to drive continual improvement
- Experience with Microsoft Office suite & Internet for business use
All your information will be kept confidential according to EEO guidelines.