Capricor Therapeutics
Quality Assurance Associate I
Capricor Therapeutics, San Diego, California, United States, 92189
Overview
Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. Our lead cell therapy in late-stage development for Duchenne muscular dystrophy is Deramiocel (CAP-1002). We are also leveraging our proprietary StealthX exosome platform to enable targeted delivery and vaccinology. This role supports clinical product launch and production, and is located at Capricor’s headquarters in San Diego, CA. Responsibilities
Support clinical product manufacturing by batch record review, label printing, product packaging, and shipping. Conduct or coordinate deviation investigations, corrective and preventive 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 word processing, tracking, issuing, distributing, and archiving, using manual or electronic document management systems. Coordinate / track / archive controlled records (e.g., batch/test records, logbooks, validation documents, labels, reports, forms) 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, and record keeping. 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. 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 is a plus. Precise attention to detail and excellent record-keeping skills. Strong 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. Work Environment / 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, and complete required paperwork. Compensation and Benefits
$65,000 - $75,000 a year. Comprehensive benefits package, including health insurance, retirement plans, and opportunities for professional development. Why Capricor?
Capricor Therapeutics is a leader in cell and exosome therapy, dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Our team is committed to patient-centered innovation and making a meaningful impact. Join us and be part of a mission-driven group transforming lives through breakthroughs in healthcare.
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Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. Our lead cell therapy in late-stage development for Duchenne muscular dystrophy is Deramiocel (CAP-1002). We are also leveraging our proprietary StealthX exosome platform to enable targeted delivery and vaccinology. This role supports clinical product launch and production, and is located at Capricor’s headquarters in San Diego, CA. Responsibilities
Support clinical product manufacturing by batch record review, label printing, product packaging, and shipping. Conduct or coordinate deviation investigations, corrective and preventive 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 word processing, tracking, issuing, distributing, and archiving, using manual or electronic document management systems. Coordinate / track / archive controlled records (e.g., batch/test records, logbooks, validation documents, labels, reports, forms) 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, and record keeping. 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. 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 is a plus. Precise attention to detail and excellent record-keeping skills. Strong 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. Work Environment / 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, and complete required paperwork. Compensation and Benefits
$65,000 - $75,000 a year. Comprehensive benefits package, including health insurance, retirement plans, and opportunities for professional development. Why Capricor?
Capricor Therapeutics is a leader in cell and exosome therapy, dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Our team is committed to patient-centered innovation and making a meaningful impact. Join us and be part of a mission-driven group transforming lives through breakthroughs in healthcare.
#J-18808-Ljbffr