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.

The Manufacturing & QC Associate II participates in both Manufacturing and Process Development activities. Relies on established SOPs and QC Testing procedures to perform the functions of the job. Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations. Can work independently in the lab directly from an SOP with moderate training. May determine methods and procedures on new assignments and may provide guidance to other support personnel. Has knowledge of commonly-used concepts, practices, and procedures within molecular biology. Capable of setting up materials or equipment for experiments. Can collect data for routine experiments with limited guidance. Relies on work priority from supervisor as well as limited experience to plan and accomplish tasks or goals.

Responsibilities are as follows, but not necessarily limited to:

• Participate in routine manufacturing of AlloMap, AlloSure and other diagnostic products, as well as development and verification activities.
• Perform quality control of reagents and routine data analysis.
• Complete documentations in accordance with cGMP.
• Routine sign off, monitoring, and maintenance of quality records including manufacturing batch records, equipment records and system monitoring records to ensure compliance
• Maintain accurate inventory, inventory controls and procurement to support production activities.
• Maintain cleanliness and orderliness of the production area.
• Ensure equipment and instruments are current with calibration and preventive maintenance.
• Assist in troubleshooting and problem solving as it relates to equipment or product related issues.
• Assist in the evaluation of non-conformances including disposition and associated preventive/corrective actions.
• Performs change management plan as required to support change requirements including product and process change, document change and deviations.
• Assist in validation activities and protocol/report generation. Assist in the execution of manufacturing improvement activities.
• Act as subject matter expert for revisions or improvements to manufacturing documents.
• Utilize manufacturing knowledge to improve process operations and affect positive change.
• Assist laboratory management as required to provide training to new personnel on Manufacturing and Quality work instructions.
• Interact with other support functions such as Reference Lab, Automation Engineering, Quality Assurance, IT, Software, etc.
• Perform other related duties and assignments as required.
• Promote a safe work environment. May provide recommendations on maintaining the safety of the work environment. Notify supervisors of all observed hazardous conditions or unsafe work practices.

Qualifications

• BA/BS in biological or life sciences and 3 to 5 years related experience in a manufacturing, clinical or industrial laboratory, or equivalent combination of related education and experience.
• Enjoys hands on laboratory work, with willingness to perform routine production, as well as project related tasks.
• Desirable experience would include high-throughput real time PCR, cGMP manufacturing, and molecular biology process development.
• Manufacturing/Development of in-vitro diagnostics would be an asset.
• Ability to handle multiple tasks and react appropriately to changing priorities and impending deadlines.
• Thrives in a highly collaborative, fast-paced, team-based environment.
• Operates well in a team-oriented, scientific environment.
• Must be able to interface and communicate effectively with team members and associated work groups to ensure completion of tasks and projects.
• Strong interpersonal, verbal and written communication skills required.
• Must be very detail oriented.
• Self-motivated, with ability to work with minimal supervision.
• Previous experience with Operational Excellence and Continuous Improvement, including Lean and Six Sigma preferred.
• Proficiency with Microsoft Word, Excel, Project, PowerPoint, Adobe Acrobat and Outlook.
• Experience with LIMS and data analysis tools desirable.

Additional Information:
We provide Medical, Dental, Vision and Life Insurance, Flexible Spending and Dependent Care, Commuter Accounts, 401(k) match, 3 weeks of vacation, 5 days sick leave, 1 personal floating holiday, 9 paid holidays, gym reimbursement, yoga onsite, ping pong, foosball, BBQ’s, social hours, and more!