Manufacturing & QC Associate II

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.

About the role

The Manufacturing & QC Associate II participates in a diverse range of Manufacturing, QC, and Process Development activities. This position relies on established controlled procedures to perform routine to complex duties 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 is essential.

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.

Requirements

• Bachelor’s degree in biological or life sciences (or related field) with a minimum of 2 years 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.

Work Environment

This is an onsite position at CareDx in Brisbane, CA. Travel is not a primary aspect of this position, although it may be requested from time to time. The role may involve working in environments where safety, environmental, and health concerns require constant attention, with adherence to corporate and regulatory policies.

Physical Demands

The physical demands described are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

• Frequent sitting, standing, and walking; periods of sitting for 3-4 hours at a time.
• Regular use of hands to operate office equipment and type on a keyboard.
• Occasional lifting and/or moving of up to 20 pounds.
• Specific vision abilities required include close vision and the ability to adjust focus.

Benefits

• 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.
• Living Donor Employee Recovery Policy: up to 30 days of paid leave annually for full-time employees who donate an organ or bone marrow.

Pay

San Francisco Bay Area roles: $68,000—$85,000 USD. The final salary offered will depend on factors such as experience, education, and industry background. This role may also be eligible for additional discretionary bonuses, incentives, and restricted stock units.