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. This position requires a high level of technical knowledge and the application of that knowledge to department testing, clinical relevance, and complex problem-solving skills. The role serves as a department resource and is responsible for assisting with department compliance with all pertinent laboratory accrediting agency and regulatory requirements (e.g., CLIA, CAP, FDA, California and New York State requirements). All functions are performed according to established policies, procedures, regulatory and accreditation requirements, as well as applicable professional standards. Core Functions:
- Perform duties of Clinical Laboratory Scientist (CLS) at a high level of competency, providing operational leadership and workflow oversight. Integrate comprehensive technical knowledge and clinical relevance into daily activities. Solve complex technical, computer, interdepartmental, and quality issues. Implement technical initiatives under the direction of the laboratory leadership team. Provide technical support for problem solving. Provide onsite supervision in the absence of the section supervisor.
- Focus on quality by reviewing records and ensuring the performance of all quality control and assurance procedures. Assist in the implementation of new QC/QA policies and continuous quality improvement programs. Participate in department and system quality assurance activities and preparation for on-site accrediting processes.
- Monitor and recognize opportunities for improvement, participating in efforts to improve the financial performance of the department and system. Assist with cost analysis models.
- Assist with basic personnel oversight, including selection, training, development, and coaching under the direction of the Supervisor. Participate in new employee orientation, training, and competency assessments. Contribute to projects and special initiatives within the department or system.
- Serve as a resource communication liaison for issues. Promote teamwork and customer service, demonstrating preceptor and coaching skills.
Minimum Qualifications:
- Bachelor's Degree in medical laboratory science/medical technology, OR
- Bachelor's degree in chemical or biological science (transcripts may be reviewed to determine eligibility) AND California Clinical Laboratory Scientist License and certified MT/MLS/CGMBS ASCP certification (MLS or categorical).
- Four (4) years' experience in nonwaived testing in the designated specialty/sub-specialty area.
- 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, data analysis, 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.
- Exceptional organizational skills; ability to work in stressful situations; attention to detail.
- Must be willing and able to be on-site full time in Brisbane, CA (South San Francisco)
Responsibilities:
- Perform, interpret, and review all tests according to standard operating procedures and policies.
- Serves as a subject matter expert within specific laboratory department
- Acts as lead in the development, evaluation, validation, and implementation of new clinical laboratory procedures, equipment, and processes
- Completes assigned projects and tasks in a timely manner with little or no supervision and engages the team in projects
- Identifies laboratory and clinical needs related to area of subspecialty expertise including projects, initiatives, quality assurance, and compliance
- Provide guidance to testing personnel performing high complexity testing
- Acts as knowledgeable leader to assist Clinical Laboratory Scientist and Assistants
- Resolves technical problems, performs advanced troubleshooting, provides thorough assessment on technical issues and decisions, and evaluate external assistance when necessary
- Reports all test results in the laboratory information system according to laboratory policies and procedures, within stated turnaround times, and follows appropriate backup procedures during computer downtimes
- Practices the proficient and safe use of all equipment necessary for the completion of all duties and responsibilities by following all maintenance, operation, safety and quality controls policies and procedures
- Demonstrates knowledge of techniques, principles, and instruments and their interrelationships as well as physiological conditions affecting test results
- Analyzes all test and quality controls and reviews for errors, inconsistencies and deviations prior to reporting results
- Initiates, documents, troubleshoot to ensure remedial actions are taken whenever test systems/QA deviate from established performance specifications
- Communicates information or problems with laboratory team and leadership in a respectful and proactive manner
- Contributes in maintaining continual compliance with policies, procedures and record keeping necessary to meet standards of accrediting or regulatory agencies
- Participates in the quality management program including quality control review, annual procedure review, compliance requirements, quality improvement, and implementation of the training and competency program
- Participate in educational and training activities to acquire new skills, maintain technical relevance and improve proficiency
- Provides patient-focused care in a clinical setting through the accurate performance of routine and complex tests through the pre-analytic, analytic and post-analytic stages
- Answers inquiries regarding specimen handling, results and other technical information
- Appropriately assists clinicians with requests and seeks out resources necessary when information is not available to answer questions
- Effectively communicates all pertinent information with appropriate laboratory staff and lab leadership
- Acts in a consistently professional manner while conducting all duties and responsibilities
- Ability to recognize strengths and weaknesses in themselves and others, can adapt to change, and remain professional in stressful situations.
- Write and update protocols to meet regulatory standards.
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 at https://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. 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. CareDx, Inc. is an Equal Opportunity Employer 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. ******** We do not accept resumes from headhunters, placement agencies, or other suppliers that have not signed a formal agreement with us. #LI-Onsite
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