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 Sr Manufacturing & QC Associate participates in a diverse range of Manufacturing, QC and Process Development activities. The position relies on established SOPs and QC Testing procedures to perform the functions of the job. Individual works on assignments that are routine to complex in nature where judgment is required in resolving problems, identifying improve opportunities and making 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 solid knowledge of commonly used concepts, practices, and procedures within molecular biology, with ability to apply technical experience to assist in troubleshooting and ongoing process improvements. Capable of setting up materials or equipment for validation studies or process development work. Can develop experimental protocols and perform data analysis with moderate guidance. Able to determine work priority independently and rely on experience to plan and accomplish tasks or goals.
Responsibilities:
- Participate in routine manufacturing of all reagents required for running CareDx’s diagnostic assays to ensure product quality requirements within established timelines and following standard workflows.
- Support requirements in development, engineering and validation/verification activities as required, including executing on protocols, data gathering and/or report generation.
- Perform quality control of reagents and data analysis to ensure products meet specifications.
- Complete documentations in accordance with GDP and ensures compliance with GLP requirements.
- Routine sign off, monitoring, and maintenance of quality records including manufacturing batch records, equipment records and system monitoring records to ensure compliance
- Support and maintain accurate inventory, inventory controls and procurement to support production activities.
- Ensure equipment and instruments are current with calibration and preventive maintenance.
- Assist in troubleshooting and problem solving as it relates to equipment, process or product related issues. May be required to support technical inquiries, perform troubleshooting experiments, and/or participate in quality audits or investigations into deviations from standard procedures.
- Assist in the writing and 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.
- Act as subject matter expert for revisions or improvements to manufacturing documents.
- Utilize manufacturing and technical knowledge to improve process operations and affect positive change.
- Acts as primary trainer and mentor to junior associates and other team members.
- Collaborate with other support functions such as CLIA, Automation Engineering, Quality Assurance, IT, Software, etc.
- Update and support established Key Performance Indicators.
- 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 supervisor of all observed hazardous conditions or unsafe work practices.
Qualifications:
- BA/BS in biological or life sciences and 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.
- Strong understanding of manufacturing processes and equipment, with solid problem-solving and analytical skills.
- Experience in high-throughput real time PCR, Next Gen Sequencing, cGMP manufacturing, and molecular biology process development strongly preferred, including hands on experience using relevant laboratory automation and instrumentation.
- Ability to handle multiple tasks and react appropriately to changing priorities and impending deadlines. Must be well organized, possess a strong work ethic, and ability to anticipate next steps pro-actively.
- Display good initiative to identify areas for improvements and implement solutions.
- Thrives in a highly collaborative, fast-paced, team-based environment. Ability to work effectively cross functionally within Operations.
- 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 understanding of Lean manufacturing principles.
- Strong proficiency with standard Microsoft Office suite and experience using manufacturing software, databases and data analytics tools.
- Responsible for adhering to all established safety protocols, procedures and guidelines.
Work Environment:
This is an onsite position at CareDx in Brisbane CA. Travel is not a primary aspect of this position although travel may be requested from time to time. An employee in this position may work in an environment, or visits facilities, in which safety, environmental and health concerns may demand constant attention. Adherence to the corporate and/or regulatory policies, rules, and regulations in these areas is required.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly required to use hands and fingers, handle or feel, and talk or hear. The employee frequently is required to sit, stand and walk. There will be periods of time during the workday where you will be sitting for 3-4 hours in a row.
Require regular use of hands to operate office equipment and type on the keyboard. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.
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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