Sr. Quality Assurance Specialist

Veracyte•San Diego, CA

11h•Hybrid

About The Position

As Senior Quality Assurance Specialist, you will work directly with stakeholders from all departments of the company to maintain an established Quality Management Systems and processes ensuring compliance with the regulatory agencies for a high complexity clinical laboratory. This role will rely heavily on effective communication, creative solutions, thorough documentation, and timely delivery. This is a HYBRID role located in San Diego, CA

Requirements

Bachelor’s degree in a Sciences discipline or equivalent with 5+ years relevant experience
Experience in a clinical testing laboratory environment (preferably molecular testing) performing Quality Assurance functions such as SOP and protocol writing or review, record and data review, investigations into deviations and out of specification results, training, and auditing.
Working knowledge of CLIA, CAP and New York regulations for a high complexity clinical laboratory and requirements for genetic testing.
Detail oriented with strong written and verbal communication skills.
Ability to work independently, within prescribed guidelines, and as a collaborative team member.
Demonstrated ability to follow detailed directions in a clinical laboratory environment.
Must be familiar with Microsoft Office applications, electronic Quality Management System (example: Media Lab, Veeva etc.)
Repetitive movement of hands, arms, legs and fingers (typing and/or writing)
Sitting, with occasional walking, standing, and moving about
Exposure to general office environment conditions
Occasionally required to lift up to 25 pounds.
Ability to travel up to 20% between all corporate site locations within USA.

Nice To Haves

Preferred experience with US FDA Quality Management System regulations, including design controls.

Responsibilities

Maintains the quality management system to ensure compliance with regulatory expectations and Veracyte requirements.
Maintains and renews State, Federal, and other certifications and licenses as deemed necessary for the operations of the Clinical Laboratory.
Reviews and approves CAPAs, Nonconforming Events and Change Controls to support process improvement.
Participates in problem solving/ troubleshooting activities as part of nonconforming event investigations.
Reviews quality records to ensure accuracy following Good Documentation Practices and related procedures.
Collaborates with cross-functional teams to prepare quality indicator reports for Quality Metrics meetings.
Conducts internal audits to ensure compliance with applicable regulatory requirements.
Participates and assists in external audits.
Assists in interacting with Government and Regulatory Agencies as appropriate on behalf of the Laboratory.
Assists in supplier qualification and reassessment activities.
Assists in scheduling Quality Events and Meetings.
Assists in training staff members on Quality Management System as necessary to ensure compliance with internal and Regulatory standards.
Participates and assists with regulatory and quality functions within Product Development Core Teams, which can include preparing and tracking regulatory submissions, document review, and project timeline tracking.
Performs other QA duties as assigned.