Quality Assurance Associate I

Capricor Therapeutics • San Diego, CA

93d • $65,000 - $75,000

About The Position

Capricor Therapeutics, a publicly traded (NASDAQ: CAPR) biotechnology leader, is driven by a mission to develop groundbreaking biologics—focusing on cell and exosome-based therapies—to make a meaningful impact on patients’ lives, particularly for severe conditions like Duchenne muscular dystrophy with our lead therapy, deramiocel (CAP-1002). Our innovative work extends to our StealthX™ exosome platform, harnessing cutting-edge science to address unmet medical needs through precision-engineered solutions. At the heart of everything we do is a deep commitment to patient-centered innovation, fueled by strong academic partnerships and a passion for advancing healthcare. 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 companywide GLP/GCP/GMP controlled documentation, training, and facility support systems. This role is located at Capricor’s headquarters in San Diego, CA.

Requirements

• Bachelor’s Degree and 2+ years of experience in a cGMP environment
• Knowledge of standard processes involved in document control and experience in an FDA regulated environment
• Experience in Aseptic Processing a plus
• Precise attention to detail
• Excellent record keeping skills
• Strong, demonstrable computer skills in MS Word, Excel, Visio, Access; Adobe suite; and database systems
• Familiar with Quality Systems and records management in a cGMP environment.
• Strong communication and problem-solving skills
• Results oriented with dedication to compliance and customer service
• Strong initiative and follow-through
• Comfortable working in a fast paced and dynamic environment.
• Ability to gown and work in a classified area as required.

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 / 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 development / improvement and implementation of material, facility and quality management systems
• Other required duties as may be assigned

Benefits

• Comprehensive benefits package, including health insurance
• Retirement plans
• Opportunities for professional development

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree