What are the responsibilities and job description for the Quality Assurance Associate II position at Capricor Inc?
Job Description
Job Description
About Capricor Therapeutics
Capricor Therapeutics is a pioneering biotechnology company dedicated to transforming the lives of patients through groundbreaking therapies for severe and complex diseases. Focused on advancing cell and exosome-based technologies, we aim to address critical medical needs, including Duchenne muscular dystrophy. Our mission to redefine healthcare through cutting-edge science is rooted in an unwavering commitment to improving patient outcomes. Join our passionate team where innovative science meets patient-centered care.
Position Overview : Quality Assurance Associate II
We are seeking a self-motivated team player with attention to detail, who enjoys organizing, making processes better, and making a difference in patient lives. The successful candidate will serve an essential role in supporting clinical product launch and production. This includes batch record review, review of raw materials, deviation investigation, label issuance, and word processing, tracking, issuing, distributing, and archiving company-wide GLP / GCP / GMP controlled documentation, training, and facility support systems.
Responsibilities :
- Support clinical product manufacturing by batch record review, label printing, product packaging, and shipping.
- Conduct or coordinate deviation investigations, corrective and preventative actions (CAPA), change controls, company-wide training, and internal audits. Write associated reports.
- Process controlled documentation through the GxP (GLP / GCP / GMP) documentation system, including but not limited to word processing, tracking, issuing, distributing, and archiving, utilizing manual or an electronic document management system.
- Coordinate, track, and archive controlled records (i.e., batch / test records, logbooks, validation documents, labels, reports, forms, etc.) for change controls, deviations, CAPAs, audits, training, equipment calibration, and preventative maintenance.
- Write and / or review policies, standards, procedures, and work instructions to document Quality documentation processes and practices.
- Support supplier and material management, including ordering, incoming receipt, record keeping, etc.
- Perform review and release of incoming materials.
- Inventory database management, including accurate and timely updating of lot numbers and quantities.
- Collaborate on the development, improvement, and implementation of material, facility, and quality management systems.
- Other required duties as may be assigned.
Requirements :
Work Environment and Physical Demands :
Why Capricor?
Capricor Therapeutics is an industry leader in cell and exosome therapy, pushing boundaries to create innovative treatments that raise the standard of care. Grounded in integrity and driven by science, our team is committed to making a meaningful impact through patient-centered innovation. Join us and be part of a team that’s changing lives—help us shape the future of healthcare.
Compensation (USD) :
Salary Range : $75,000 - $80,000 annually
Comprehensive benefits package, including health insurance, retirement plans, and opportunities for professional development.
Come work with us!
At Capricor, we offer a collaborative work environment that supports your professional growth. Join a passionate team committed to transforming the lives of patients and pushing the boundaries of medical science.
Salary : $75,000 - $80,000
