Quality Assurance Lead

Responsibilities

• Managing the electronic Quality Management System (EQMS) to assure compliance to in-house and/or external specifications and standards such as GMPs and CLIA.
• Includes basic system administrator responsibilities, creating new hire accounts, assigning training requirements, account terminations, training to users on how to use the EQMS, system maintenance such as periodic upgrades and troubleshooting.
• Lead Quality System processes for Corrective/Preventive Actions, Supplier Corrective Actions, Supplier Qualifications, Complaints, Non-conforming Materials and Management reviews.
• Quality review of procedures, forms, and other materials in collaboration with other departments.
• Provide general guidance to personnel on quality requirements.
• Support GCLP compliance and audits.
• Participate in external and internal audits as needed.
• Participate in development projects to support design controls and risk management processes.

Qualifications

• Bachelor of Science degree in scientific field is preferred with at least 5-8 years of related experience in Quality Assurance.
• General knowledge and understanding of FDA/QMSR and CLIA.
• 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 with FDA, CLIA, CAP, NY State audits and inspections preferred.
• Knowledgeable in supplier control and supplier monitoring.
• 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.

Additional Details

Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients. Our Competitive Total Rewards Package For US Employees Includes:

• Competitive base salary and incentive compensation
• Health and welfare benefits, including a gym reimbursement program
• 401(k) savings plan match
• Employee Stock Purchase Plan
• Pre-tax commuter benefits
• And more!

Please refer to our page to view detailed benefits at https://caredx.com/company/careers.

CareDx, Inc. is an Equal Opportunity Employer-vets/disabled, and participates in the E-Verify program. By proceeding with our application and submitting your information, you acknowledge that you have read our U.S. Personnel Privacy Notice and consent to receive email communication from CareDx. Certain jurisdictions require notice of how we use and protect your personal information. For more information, please read our Privacy Policy

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