QUALITY ASSURANCE ASSOCIATE III

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 IIIWe are seeking a self-motivated team player who is meticulous and has a keen eye for detail. The successful candidate should have a knack for organization, a drive for improving processes, and a desire to make a difference in patient lives. The selected candidate will serve an essential role in supporting clinical product launch and production. Responsibilities include batch record review, deviation investigation, label issuance, and tracking, issuing, distributing, and archiving company-wide GLP / GCP / GMP controlled documentation, training, and facility support systems.

Responsibilities: 

• Support clinical product manufacturing by conducting batch record review/disposition, label printing, product packaging, and shipping.
• Working knowledge of 21 CFR 210 and 211, ICH, ISO9001, EU Guidelines, and other relevant FDA regulations is a must.
• 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.
• Collaborate on the development, improvement, and implementation training program, and other quality management systems, as assigned.
• 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 management program.
• Inventory database management, including accurate and timely updating of lot numbers and quantities.
• Perform review and release of incoming materials.
• Support regulatory/submission activities.
• Ability to participate and prepare relevant materials for Management Review and Material Review Board meetings.
• Perform other required duties as may be assigned.

Requirements: 

• Bachelor’s Degree and 3-5 years of experience in a cGMP environment.
• Experience in a commercial cell therapy company is highly desired.
• Experience in Aseptic Processing is a plus.
• Attention to detail and excellent record-keeping skills.
• Strong, demonstrable computer skills in MS Word, Excel, Visio, Access; Adobe suite; and database systems.
• Good oral and strong written communication skills.
• Familiarity with Quality Systems and records management in a cGMP environment.
• Strong problem-solving skills and the ability to coordinate and perform multiple activities.
• Results-oriented with dedication to compliance and customer service.
• Strong initiative, independence, and follow-through.
• Comfortable working in a fast-paced, cross-functional team in a dynamic environment.
• Comfortable dealing with rapidly changing priorities.
• Ability to gown and work in a classified area as required.

Work Environment and Physical Demands: 

• Must be able to sit and stand for extended periods.
• Must be able to lift/carry reports and materials up to 40 pounds, move about the office, communicate efficiently and effectively on the telephone or in person, and complete required paperwork. 

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: $85,000 - $90,000 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.