Veracyte, Inc. · 15 hours ago
Sr. Quality Assurance Specialist
San Diego, CA
Full-time
Hybrid
Mid, Senior Level
$95K/yr - $118K/yr
5+ years expVeracyte, Inc. is a global diagnostics company committed to transforming cancer care for patients across the globe. As a Senior Quality Assurance Specialist, you will maintain the Quality Management Systems and processes to ensure compliance with regulatory agencies in a high complexity clinical laboratory setting.
BiotechnologyHealth CareHealth Diagnostics
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
Qualification
Required
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.)
Preferred
Preferred experience with US FDA Quality Management System regulations, including design controls
Benefits
Competitive compensation and benefits
Additional discretionary bonuses/incentives
Restricted stock units
Company
Veracyte, Inc.
Veracyte is a global diagnostics company that empowers clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer.
501-1000 employees
H1B Sponsorship
Veracyte, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (17)
2023 (7)
2022 (2)
2021 (6)
2020 (8)
Funding
Current Stage
Public CompanyTotal Funding
$1.1BKey Investors
Visium Healthcare PartnersGE VenturesDomain Associates
2021-02-05Post Ipo Equity· $550M
2020-08-05Post Ipo Equity· $194M
2019-05-01Post Ipo Equity· $137.8M
Leadership Team
John Leite
Chief Commercial Officer (CCO)
Recent News
2026-01-12
TradingView
2026-01-12
Company data provided by crunchbase