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.
The Sr Quality Specialist plays an integral role on the Quality team & supports the company's compliance activities with the FDA Quality System Regulation & ISO 13485 as well as CLIA, CAP, & applicable state requirements. The Sr Quality Specialist works closely with a wide variety of departments to support quality activities & identify opportunities for continual improvement.
Essential Duties & Responsibilities:
- Responsible for implementation & maintenance of the internal audit program.
- Responsible for creating annual internal audit schedule, developing internal audit plans & coordinating activities with cross-functional teams
- Function as a lead auditor for internal audits & perform audits to ensure compliance to internal & external requriements
- Provide recommendations for continuous improvement to strengthen the internal processes & structure
- Document audit findings & monitor corrective actions associated with the audit findings until closure
- Conduct re-audits as necessary to address identified compliance gaps & to follow up on corrective/preventive actions as necessary & appropriate
- Create & maintain quality metrics required for management review
- Develop & maintain procedures & records that demonstrate compliance to the internal aduit program, & the company's QMS
- Provide training, guidance, & support the company for other QMS related activities
- Support routine Quality processes such as investigating non-conformances, CAPAs, complaints, other process monitoring activities
- Ability to independently develop solutions for complex problems
- Ensure processes are in place that lead to the delivery of quality results & continually assess their effectiveness to drive continual improvement
- 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
- 5+ years of experience in the Life Sciences Industry, preferably in IVD regulated environment
- Strong working knowledge of FDA QSR, ISO 13485, ISO 14971 regulations
- Experience in compliance with quality standards in a regulated Molecular laboratory preferred
- Certified ISO 13485 lead auditor preferred
- Effective verbal & written communication skills & ability to share & receive information from all levels of the organization throughout various departments
- 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
- Experience with Microsoft Office suite & Internet for business use
All your information will be kept confidential according to EEO guidelines.