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 Manufacturing & QC Associate II participates in a diverse range of Manufacturing, QC and Process Development activities. The position relies on established controlled procedures to perform the duties of the job. Individual work on assignments that are routine to complex in nature where judgment is required in resolving problems, identifying improvement opportunities and making recommendations. Ability to work independently in the lab directly from an SOP with proper training. This position will require knowledge of commonly used concepts, practices, and procedures within molecular biology. Ability to apply technical experience to assist in troubleshooting and ongoing process improvements.
Responsibilities:
- Execute routine manufacturing of reagents for CareDx diagnostic assays, including support for development, verification, and validation activities.
- Perform quality control testing and data analysis to ensure reagent integrity and compliance with specifications.
- Maintain accurate and compliant documentation in accordance with cGMP standards, including batch records, equipment logs, and system monitoring reports.
- Monitor and maintain inventory of raw materials and finished goods to support uninterrupted production.
- Ensure production areas remain clean, organized, and audit-ready, adhering to safety and contamination control protocols.
- Verify calibration and preventive maintenance status of laboratory equipment and instruments.
- Support troubleshooting and root cause analysis for equipment, process, or product-related issues.
- Participate in non-conformance investigations, including disposition decisions and implementation of corrective/preventive actions (CAPA).
- Contribute to change management activities, including documentation updates, process modifications, and deviation resolutions.
- Lead or support validation efforts, including protocol development, execution, and report generation.
- Provide input on manufacturing document revisions and process optimization, ensuring clarity and efficiency.
- Assist in onboarding and training of new personnel, promoting adherence to manufacturing procedures and operational protocols.
- Independently prioritize tasks and manage workload, ensuring timely completion of assignments in a dynamic environment.
- Perform additional duties as assigned, contributing to team success and operational excellence.
Qualifications:
- Bachelor's degree in biological or life sciences (or related field) with a minimum of 2 year of relevant experience in manufacturing, clinical, or industrial laboratory settings.
- Hands-on laboratory experience, with a strong commitment to both routine production and project-based initiatives.
- Preferred expertise in high-throughput real-time PCR, Next Generation Sequencing (NGS), cGMP manufacturing, and molecular biology process development.
- Proficiency in laboratory automation and instrumentation, including setup, operation, and troubleshooting.
- Demonstrated ability to manage multiple priorities in a fast-paced, deadline-driven environment.
- Strong collaboration skills, with the ability to work cross-functionally and contribute to a team-oriented culture.
- Excellent communication skills, both verbal and written, with the ability to interface effectively across departments.
- Detail-oriented and self-motivated, capable of working independently with minimal supervision.
- Experience with Operational Excellence and Continuous Improvement methodologies preferred.
- Proficiency in Microsoft Office Suite (Word, Excel, Project, PowerPoint, Outlook) and Adobe Acrobat.
- Familiarity with LIMS, databases, and statistical/data analysis tools is highly desirable.
This is an onsite position at CareDx in Brisbane CA. Travel is not a primary aspect of this position although travel may be requested from time to time. An employee in this position may work in an environment, or visits facilities, in which safety, environmental and health concerns may demand constant attention. Adherence to the corporate and/or regulatory policies, rules, and regulations in these areas is required.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee frequently is required to sit, stand and walk. There will be periods of time during the workday where you will be sitting for 3-4 hours in a row. Require regular use of hands to operate office equipment and type on the keyboard. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
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
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-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
The U.S. EEO posters are available here.
Note: We do not accept resumes from headhunters, placement agencies, or other suppliers that have not signed a formal agreement with us.
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