Quality Assurance Associate

Capricor Therapeutics•San Diego, CA

11h•$65,000 - $75,000•Onsite

About The Position

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel ( CAP-1002 ), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. 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
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.

Nice To Haves

Experience in Aseptic Processing a plus

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