This is an opportunity for a Quality professional to work in a diverse and complex environment and be involved in new and innovative products. Embrace working with multiple departments in a variety of Quality related functions and responsibilities. The Quality Assurance (QA) Specialist is responsible to ensure compliance to applicable quality system regulations, and software standards. The QA Specialist will collaborate inter- and intra-departmentally to implement and support quality system processes in support of CLIA and FDA regulations. This requires effective partnerships with personnel internally, in the field and at other CareDx sites. Requires ability to problem solve, work independently and to function in a team environment. Additionally, may require participation in cross functional project teams and provide Design Control guidance for LDT and IVD regulated products.

Responsibilities:

• Managing the electronic Quality Management System(EQMS) system to assure compliance to in­house 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 EDMS, system maintenance such as periodic upgrades
• Processing quality system records such as Corrective/Preventive Actions, Supplier Corrective Actions, Supplier Qualifications, Complaints, Non-conforming Materials
• Manufacturing batch record reviews
• Quality review of procedures, forms, and other materials in collaboration with other departments
• Provide general guidance to personnel on quality requirements
• Participate in external and internal audits as needed
• Any other duty as assigned by QA department management

Qualifications:

• Bachelor of Science degree in scientific field preferred with at least 3-5 years of related experience in Quality Assurance.
• General knowledge and understanding of FDA/QSR and CLIA
• Experience in a CLIA-regulated laboratory environment and strong knowledge of Clinical regulations (Clin/Reg) 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 compliance and 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 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!

In addition, we have a Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow.

With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it’s an exciting time to be part of the CareDx team. Join us in partnering with transplant patients to transform our future together.