Manufacturing & QC Associate II

CareDx, Inc. • Brisbane, CA

5h • $68,000 - $85,000 • Onsite

About The Position

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.

Requirements

• 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.
• 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.
• Proficiency in Microsoft Office Suite (Word, Excel, Project, PowerPoint, Outlook) and Adobe Acrobat.

Nice To Haves

• Preferred expertise in high-throughput real-time PCR, Next Generation Sequencing (NGS), cGMP manufacturing, and molecular biology process development.
• Experience with Operational Excellence and Continuous Improvement methodologies preferred.
• Familiarity with LIMS, databases, and statistical/data analysis tools is highly desirable.

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.

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 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level