Capricor Therapeutics, Inc.
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.
Position Overview:
Quality Assurance Specialist, Clinical
We’re looking for a Quality Assurance Specialist who is detail-oriented, self-motivated, and a strong team player. The ideal candidate will have excellent organizational skills, a passion for process improvement, and a commitment to supporting work that makes a difference in patients’ lives. This role will be critical in supporting clinical product launches and production. Key responsibilities include batch record review, deviation investigations, label issuance and tracking, as well as managing companywide GLP/GCP/GMP-controlled documentation, training systems, and facility support. This position is onsite in Vista, CA. Knowledge of standard processes involved in document control and experience in an FDA regulated environment is required 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. 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 raw material 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, as required 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 5-7 years of experience in a cGMP environment Experience in 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 and dynamic environment Comfortable dealing with rapidly changing priorities 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, communicate efficiently and effectively on the telephone or in person, and complete required paperwork Why Capricor?
Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough. Come Work With Us!
At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Compensation (USD): Salary Range: $100,000 to $110,000 annually. This role offers competitive compensation based on experience and qualifications. Additional benefits include health insurance, retirement plans, and opportunities for professional development.
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Quality Assurance Specialist, Clinical
We’re looking for a Quality Assurance Specialist who is detail-oriented, self-motivated, and a strong team player. The ideal candidate will have excellent organizational skills, a passion for process improvement, and a commitment to supporting work that makes a difference in patients’ lives. This role will be critical in supporting clinical product launches and production. Key responsibilities include batch record review, deviation investigations, label issuance and tracking, as well as managing companywide GLP/GCP/GMP-controlled documentation, training systems, and facility support. This position is onsite in Vista, CA. Knowledge of standard processes involved in document control and experience in an FDA regulated environment is required 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. 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 raw material 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, as required 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 5-7 years of experience in a cGMP environment Experience in 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 and dynamic environment Comfortable dealing with rapidly changing priorities 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, communicate efficiently and effectively on the telephone or in person, and complete required paperwork Why Capricor?
Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough. Come Work With Us!
At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies. Compensation (USD): Salary Range: $100,000 to $110,000 annually. This role offers competitive compensation based on experience and qualifications. Additional benefits include health insurance, retirement plans, and opportunities for professional development.
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