Clinical Quality Specialist

Company Description

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn , X (Twitter) and Facebook .

Essential Duties and Responsibilities:

• Maintain accurate documentation and/or any associated documentation for all quality activities according to internal requirements for material receipt, batch record review, equipment maintenance and qualification documentation. and supplier files.
• Support processes such as non-conformance, CAPA, and Quality metrics
• Support Purchasing and Development teams in the evaluation and selection of suppliers
• Responsible for supplier onboarding and maintenance of approved supplier list (ASL)
• Review supplier change notifications, coordinate activities with suppliers and internal cross-functional support teams for review
• Supporting supplier and regulatory audits, as required
• Provide day-to-day quality support for equipment such as maintenance, installation/operational/performance qualifications, relocations, and decommissions.
• Create and maintain quality metrics required for team and management review
• Identifies opportunities for continual improvement and works with management and team members to successfully address these opportunities
• Performs other related duties and responsibilities as assigned
• Report and document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable
• Assist in ERP transactions as required

Qualifications:

• Typically requires a university degree and no previous professional experience.
• Working knowledge of FDA regulations and ISO 13485 standards as required
• Experience with utilizing a Laboratory Information Management System and ERP system are highly recommended
• Support the documentation and review activities for equipment
• Knowledge of incoming material processes
• Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
• Effective problem-solving and analytical skills are recommended
• Effective verbal and written communication skills and ability to share and receive information from
• all levels of the organization throughout various departments
• Ability to work effectively in a team environment and build strong working relationships
• Ability to identify, analyze, solve problems and escalate concerns to management
• Attention to detail and accuracy

Work Environment:

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Hybrid Work Model: This section is applicable to onsite employees who are eligible for hybrid work location as specified by management and related policies. Guardant has 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.

The annualized base salary ranges for the primary location and any additional locations are listed below. This range does not include benefits or, if applicable, bonus, commission, or equity. Each candidate’s compensation offer will be based on multiple factors including, but not limited to, geography, experience, education, job-related skills, job duties, and business need. Primary Location: Redwood City, CA Primary Location Base Pay Range: $75,300 - $103,550 Other US Location(s) Base Pay Range: $64,000 - $88,050 If the role is performed in Colorado, the pay range for this job is: $67,800 - $93,200