Manufacturing & QC Associate I

Title: Manufacturing & QC Associate I

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 I will be an integral part of the Lab Services team, responsible for producing high-quality reagents to support patient testing in our Clinical Lab. This role includes participation in routine manufacturing and process development activities and provides support in troubleshooting and process improvement efforts. The Manufacturing & QC Associate I reports directly to the Supervisor, Manufacturing & QC. This is a full-time onsite position based in our Brisbane, CA Clinical Lab.

Responsibilities:

• Participate in the routine manufacturing and quality control of reagents required for diagnostic assays, including inspection of raw materials and consumables.
• Assist in resolving routine problems that arise in the manufacturing process and escalate issues as needed.
• Assist in scheduling and prioritizing production tasks to meet customer demand and ensure efficient operation of the Manufacturing department.
• Support process development, product transfer, and validation activities, as needed.
• Work collaboratively with various departments (e.g., CLIA Lab, Quality Assurance, Supply Chain, R&D, Automation and Process Engineering) on cross-functional projects and activities.
• Utilize established SOPs and QC testing procedures, maintain accurate records, and assist in developing new documentation as needed.
• Work with Supply Chain to ensure adequate supply and material replenishment, maintaining accurate inventory records.
• Support Quality Management System guidelines, participate in internal audits, and ensure compliance with cGMP standards.
• Promote a safe work environment and adhere to all EH&S regulations and requirements.
• Perform other related duties and assignments as required.

Qualifications:

• BA/BS in Biological or Life Sciences with at least 0-3 years of related experience in a Manufacturing or Clinical Laboratory environment.
• Knowledge and hands-on experience in molecular biology concepts and techniques. Familiarity with reagent manufacturing, real-time PCR and/or NGS workflows is preferred.
• Good problem-solving skills and escalate quality issues in a timely manner.
• Ability to work as part of a high performing team and collaborate effectively with staff.
• Ability to follow instructions and learn new things quickly.
• Good time management skills and ability to multitask effectively.
• Ability to work independently, but also within a team environment.
• Self-motivated, well organized with good attention to detail.
• Ability to adapt and work in a dynamic environment.
• Highly organized with the ability to multi-task and adapt to changing priorities and deadlines.
• Strong interpersonal, verbal, and written communication skills. Ability to effectively communicate in one-on-one or group settings.
• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.

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.

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