Manufacturing Process Specialist
1 week ago
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.
We are seeking an experienced Manufacturing Process Specialist to join our team. This role will be responsible for participating in both Manufacturing and Process Development activities, relying on established SOPs and QC Testing procedures to perform functions.
About the JobThe Sr Manufacturing & QC Associate participates in routine manufacturing of AlloMap, AlloSure and other diagnostic products, as well as development and verification activities. The ideal candidate will have a BA/BS in biological or life sciences and 5 to 7 years related experience in a manufacturing, clinical or industrial laboratory, or equivalent combination of related education and experience.
The successful candidate will have experience with high-throughput real time PCR, cGMP manufacturing, and molecular biology process development. Additionally, they will have strong interpersonal, verbal and written communication skills, and be able to interface and communicate effectively with team members and associated work groups to ensure completion of tasks and projects.
This role offers a competitive salary range of $85,000 - $110,000 per year, depending on experience, plus benefits including 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.
Key Responsibilities- 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.
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