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.
The Supervisor, Pre-Analytical will oversee the intake and accessioning of specimens submitted to the CareDx clinical laboratory for testing. This position currently will manage the performance of the laboratory staff as it relates to the intake and accessioning of specimens, and all associated tasks, and be responsible for ensuring staff are trained and standard operating procedures are followed. Additionally, this position is expected to accession samples up to 50% of the time to assist the team on peak volume days, and during staff absences and vacations.
The Supervisor, Pre-Analytical serves as a liaison between specimen handling area and customer services, Reflab clinical laboratory, and laboratory services/field training as well as the Clinical Operations team to coordinate specimen receipt and tracking of study specimens. This position is also responsible for the development of applicable SOPs, quality and operational metrics, trending of metrics and implementing process improvements as necessary.
Responsibilities:
- Supervise the overall operation of the Laboratory Support function
- Ensure day-to-day staffing and scheduling for the accessioning and laboratory support function meets requirements; assist with accessioning on peak days and during staff absences.
- Ensure work is consistently completed according to department goals and standard operating procedures
- Partner with other members of laboratory management team to hire shared staff; oversee training on accessioning and laboratory support activities for new hires in collaboration with the laboratory supervisors
- Collaborate with Clinical Operations to organize the sample logistics and track incoming samples submitted for testing as part of investigator initiated trials and other company-sponsored studies.
- Develop and maintain standard operating procedures (SOPs) related to the intake and accessioning of specimens.
- Handle employee issues that relate to accessioning and laboratory support; collaborate with laboratory supervisors and management to resolve issues.
- Provide input to performance management for accessioning staff.
- Develop and track quality and operational metrics; present data at weekly, monthly and quarterly operations and quality meetings; recommend and implement process improvements
- Investigate and document accessioning errors and non-conformances; initiate and manage CAPAs as necessary.
- Ensure compliance with all regulatory agency requirements
- Other duties as assigned
Qualifications:
- Bachelor’s degree in life sciences, or equivalent combination of science education and work experience.
- Strong desire and proven ability to work collaboratively and cross functionally on company initiatives. Experience leading improvement projects to achieve process efficiencies and scale the accessioning function to build capacity.
- 3-5 years related experience in a clinical laboratory environment. Must have a working knowledge of CLIA, CAP, California and New York quality system principles related to specimen collection, receipt and handling.
- Minimum of 2 years supervisory experience in a CLIA lab environment and strong leadership skills to foster a high performance, teamwork oriented laboratory environment.
- Strong interpersonal skills and high communication proficiency both verbal and written, in technical and non-technical domains.
- Excellent computer skills; ability to navigate easily through Microsoft Office; ability to monitor key metrics and generate quality and operational reports.
- Demonstrated task leadership with timely achievement of goals.
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.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.
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