What are the responsibilities and job description for the QUALITY ENGINEERING ASSOCIATE II position at Capricor Inc?
Job Description
Job Description
About Capricor Therapeutics
Capricor Therapeutics is a biotechnology company dedicated to developing transformative therapies for rare diseases, with a primary focus on Duchenne muscular dystrophy (DMD). We are pioneers in cell therapy and exosome-based technology, leveraging our proprietary StealthX™ platform to engineer innovative treatments. Our team is committed to harnessing cutting-edge science and advanced technologies to meet the unmet needs of patients living with DMD and other challenging medical conditions. Join us on our journey as we push the boundaries of medical science and pave the way for a healthier future.
About the Role
We are seeking a Quality Engineering Associate II to join our R&D group. This position will work in collaboration with the Quality Engineering team to support operations and continuous improvement efforts for the Vista Capricor GMP Facility. This role will ensure compliance with Capricor procedures and all applicable regulatory guidelines.
Responsibilities :
- Work collaboratively with other site functions such as manufacturing, Facilities, Safety, and the quality organization.
- Collaborate with the Quality Engineering team to identify process improvements and recommend changes.
- Assist in the review of Calibrations, Preventive Maintenance, and service reports for Equipment’s and Facilities.
- Provide Quality support of the change control technical assessment / evaluation process.
- Prepare reports and documents for review related to Equipment / Facilities and maintenance activities.
- Ensure alignment of equipment / facilities and IT systems qualification with Capricor’s procedures.
- Support regulatory inspections and audits.
- Conduct risk assessments using appropriate tools such as Failure Mode Effects Analysis (FMEA), Risk Matrix, Decision Tree, etc.
- Support vendor qualification and compliance audits, technical / investigation reports as appropriate.
- Track, review and report metric information for use in continuous improvement of areas of responsibility.
- Support continuous improvement initiatives and projects within the site’s quality organization.
- Perform other duties as required.
Requirements :
Preferred Skills :
Work Environment / Physical Demands :
Compensation (USD) :
Salary Range : $75,000 - $85,000 annually
This role offers a competitive salary based on experience and qualifications. Additional benefits include health insurance, retirement plans, and opportunities for professional development.
Location Policy :
This position is based at our headquarters in San Diego, California, with flexibility for occasional remote work as needed.
Come Work With Us!
Capricor Therapeutics is headquartered in San Diego, California. We offer competitive compensation and benefits, generous vacation and parental leave, flexible working hours, and a collaborative work environment. If you are excited about joining a team that’s transforming the biotech industry, we’d love to hear from you!
Salary : $75,000 - $85,000
