CLIA Quality Specialist

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.

We are seeking a CLIA Quality Specialist to evaluate, design and implement the lab quality assurance program to ensure that the laboratory is compliant to the regulatory requirements for the continued accreditation and certification of CAP and CLIA. The Clinical Diagnostics QA Specialist will be responsible for monitoring the Lab Quality Management program, implement new plan for improvement and to meet with updated requirements. This individual will maintain all documents including SOP, policies and forms pertaining to the lab operations.

Responsibilities include, but not necessarily limited to:

• Ensure all laboratory activities are performed in accordance with CAP/CLIA/NY State requirements.
• Manage the review and development of technical SOPs, to ensure compliance with appropriate regulations.
• Design, develop and implement new QC procedures.
• Monitor SOP implementation as designed.
• Performs QC review, ensuring appropriate corrective action and documentation according to standard operating procedure.
• Monitors and reviews non-conforming events, ensuring appropriate corrective action is completed.
• Utilizes root cause analysis to evaluate non-compliance or non-conforming events requiring correction. Recommends actions and communicates with management the analysis and recommendations for quality improvement.
• Use of metrics, benchmarks, and indicators to track quality performance.
• Is responsible for Proficiency Testing scheduling and events.
• Performs internal audits (CAP interim, competency assessments, quality indicators, periodic audit of QM Plan)
• Maintains and updates all documentation required for licensure purposes.
• Monitors and maintains all training and competency documentation for technical staff.
• Demonstrate continuous self-motivated quality development proactively taking steps to improve quality systems.
• Provides educational presentations and trainings to Clinical Laboratory staff to ensure quality improvement.
• Knowledge and proficiency in the use of word processing, spreadsheet, and graphical computer programs.
• Ability to use and understand basic statistical concepts and methods that are commonly utilized in clinical laboratory science.
• Ability to interact in a professional manner with individuals at all levels and maintain open lines of communication with the Clinical Laboratory Manager concerning any technical or personnel issues.
• Exceptional organizational skill, ability to work in stressful situations and attention to detail.
• Oversee CGMBS training program

Required Qualifications:

• California Clinical Laboratory Scientist License and certified MT/MLS ASCP.
• Previous supervisory experience in high complexity.
• Bachelor's or advanced degree in clinical laboratory science, molecular biology, or related field of laboratory science (biology, microbiology, chemistry, biochemistry, physics) from an accredited college or university.
• A minimum of four years prior laboratory work experience required for individuals with a bachelor's degree.
• Demonstrated subspecialty expertise, knowledge or training as may be deemed appropriate for the laboratory section.
• Knowledge and proficiency in the use of word processing, spreadsheet, and graphical computer programs.

Preferred Qualifications:

• Willingness to be on-site 100% of the time. The position is located at our headquarters in Brisbane, CA.

An important aspect of CareDx's culture is that we are passionate about what we do, and we are all willing roll up our sleeves to get the job done. We are looking for a Quality Assurance Specialist who fits that expectation and who will prosper in our culture.

San Francisco Bay Area Roles:

The anticipated base salary range for candidates who will work in Brisbane, California is $150,000 to $160,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives, and restricted stock units. CareDx is a multi-state employer, and this salary range may not reflect positions that work in other states.

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!
• Please refer to our page to view detailed benefits athttps://caredx.com/company/careers/

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.

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