Clinical Quality Specialist (Sr)

Job Description

The Senior Clinical 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 Senior Clinical Quality Specialist works closely with a wide variety of departments to support quality activities and identify opportunities for continual improvement.

• Manage all aspects of Guardant Health's non-conforming event system including corrective and preventative action program
• Manage the documentation and approval for all deviations
• Provide Quality new hire training on Quality processes
• Maintain all NER, CAPA, and DAR records
• Coordinate proficiency program
• Act as a back-up for the document control system
• Create and maintain quality metrics required for management review
• 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 makes recommendations for corrective actions
• Execute special projects as assigned
• Report and document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable.

Qualifications

• B.S. degree in a scientific discipline
• 3 - 5years 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

All your information will be kept confidential according to EEO guidelines.

Employee may be required to lift routine office supplies up to 20 lbs and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposed to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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