Caredxinc
Quality Assurance Lead
Brisbane, CA · Full-time
Sponsorship not specifiedDetected 6 days ago
Product ManagementExcelFDA RegulatoryBioinformaticsPCRCommunicationCollaborationProblem SolvingMicrosoft Office
About the role
- CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers.
- CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients.
- Success in this role requires strong problem-solving skills, the ability to work independently while thriving in a team-oriented environment, and a passion for partnering across departments to achieve shared goals.
Responsibilities
- Lead Quality System processes for Corrective/Preventive Actions, Supplier Corrective Actions, Supplier Qualifications, Complaints, Non-conforming Materials and Management reviews
- Support GCLP compliance and audits
- Participate in development projects to support design controls and risk management processes
Requirements
- Experience in a CLIA-regulated laboratory environment and strong knowledge of Laboratory regulations desirable
- Experience with administrator responsibilities for commercially available document control databases strongly desired
- Experience in performing internal and external quality audits
- Experience with PCR or RUO or IVD sequencing assays desirable
- Computer skills competency including Excel, Word and PowerPoint programs required
- Demonstrated ability to present to upper Management.
- General knowledge and understanding of FDA/QMSR and CLIA
- Knowledgeable in supplier control and supplier monitoring
Nice to have
- Bachelor of Science degree in scientific field is preferred with at least 5-8 years of related experience in Quality Assurance.
- Experience with FDA, CLIA, CAP, NY State audits and inspections preferred
Compensation
- Competitive base salary and incentive compensation
Benefits
- Health and welfare benefits, including a gym reimbursement program
- Employee Stock Purchase Plan
- Pre-tax commuter benefits
- Please refer to our page to view detailed benefits at https://caredx.com/company/careers
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