Manufacturing & QC Associate II — Lab Process Excellence

CareDx; Brisbane (CA); On-site; USD 68,000 - 85,000; Full time

Benefits offered by this job

Competitive base salary

Health and welfare benefits

Gym reimbursement program

Job summary

CareDx, Inc. is seeking a Manufacturing & QC Associate II for an onsite Brisbane, CA role. The position involves routine reagent manufacturing, QC testing, documentation, and inventory control to support continuous production of diagnostic assays.

The candidate will work with SOPs, assist in troubleshooting, CAPA, and change management, and participate in validation activities. A degree in biology with 2+ years in relevant settings is required, along with strong teamwork and communication skills.

Qualifications

• Bachelor’s degree in biological or life sciences (or related field) with a minimum of 2 years in manufacturing, clinical, or industrial lab settings.
• Hands-on laboratory experience with a strong emphasis on routine production and project initiatives.
• Preferred expertise in high-throughput real-time PCR, NGS, cGMP manufacturing, and molecular biology process development.
• Proficiency with lab automation and instrumentation, including setup, operation, and troubleshooting.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong cross-functional collaboration and communication skills.
• Detail-oriented and self-motivated with independent work capability.
• Experience with Operational Excellence and Continuous Improvement methodologies is preferred.

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 per cGMP, including batch records and equipment logs.
• Monitor and maintain inventory of raw materials and finished goods to support uninterrupted production.
• Ensure production areas remain clean, organized, and audit-ready with safety and contamination controls.
• Verify calibration and preventive maintenance status of laboratory equipment.
• Support troubleshooting and root cause analysis for equipment, process, or product issues.
• Participate in non-conformance investigations and CAPA implementation.
• Contribute to change management activities and deviation resolutions.
• Lead or support validation efforts, including protocol development and report generation.
• Provide input on manufacturing document revisions and process optimization.
• Assist in onboarding and training of new personnel, ensuring adherence to procedures.
• Independently prioritize tasks and manage workload in a dynamic environment.

Skills

Laboratory skills

Hands-on experience

Communication skills

Collaboration

Detail-oriented

Multitasking

Education

Bachelor’s degree in biological or life sciences

Tools

LIMS

Microsoft Office

Adobe Acrobat

Job description

CareDx, Inc. is seeking a Manufacturing & QC Associate II for an onsite Brisbane, CA role. The position involves routine reagent manufacturing, QC testing, documentation, and inventory control to support continuous production of diagnostic assays.

The candidate will work with SOPs, assist in troubleshooting, CAPA, and change management, and participate in validation activities. A degree in biology with 2+ years in relevant settings is required, along with strong teamwork and communication skills.