Sarah Gale

Quality Assurance Associate i, Operations @Capricor Therapeutics, Inc.

San Diego, CA, US

Supports clinical product manufacturing by batch record review, label printing, product packaging, and shipping• Conducts/coordinates deviation investigations, corrective and preventative actions (CAPA), change controls, company-wide training, and internal audits while writing associated reports • Processes 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• Coordinates/tracks/archives 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• Writes and/or reviews policies, standards, procedures and work instructions to document Quality documentation processes and practices• Supports supplier and material management, including ordering, incoming receipt, record keeping etc.• Manages inventory database including accurate and timely updating of lot numbers and quantities• Collaborates on development/improvement and implementation of material, facility and quality management systems

California State University San Marcos

Bachelor's degree

UC San Diego Extended Studies

Regulatory Affairs Essentials - Certification