Capricor Therapeutics, Inc.
Quality Assurance Associate II/III
Capricor Therapeutics, Inc., San Diego, California, United States, 92189
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
Quality Assurance Associate III
to join our team. This role is critical in scaling clinical production activities, ensuring compliance with cGMP and regulatory standards. The position involves batch record review, deviation investigations, label issuance, and management of controlled documentation across GLP/GCP/GMP systems. The ideal candidate is detail-oriented, organized, and passionate about driving quality excellence in a fast-paced environment.
Responsibilities
Lead batch record review and disposition for clinical product manufacturing, including label issuance, product packaging, and shipping activities.
Own deviation investigations and CAPA processes, ensuring timely resolution and compliance; author and approve associated reports.
Drive change control evaluations and oversee implementation of approved changes.
Manage controlled documentation within the GxP system (GLP/GCP/GMP), including issuing, tracking, distributing, and archiving records using electronic document management systems.
Develop and enhance quality management systems, including training programs, SOPs, and standards; provide guidance and mentorship to junior team members.
Coordinate and maintain controlled records (batch/test records, logbooks, validation documents, labels, reports, forms) for audits, training, equipment calibration, and preventive maintenance.
Author and approve policies, standards, procedures, and work instructions to ensure compliance and operational excellence.
Lead supplier quality activities, including qualification, monitoring, and performance reviews.
Oversee inventory database accuracy, including lot number tracking and timely updates; approve release of incoming materials.
Represent QA during regulatory inspections and internal audits, preparing and presenting relevant documentation.
Contribute to regulatory submission activities and ensure readiness for management and material review boards.
Champion continuous improvement initiatives across QA processes and systems.
Requirements
Bachelor’s degree in a scientific discipline (Life Sciences, Engineering, or related field).
3–5 years of progressive QA experience in a cGMP-regulated environment.
Demonstrated expertise in batch record disposition, deviation/CAPA management, and change control oversight.
Strong knowledge of FDA regulations (21 CFR Parts 210/211), ICH guidelines, and quality systems.
Ability to author and approve SOPs and quality documentation; experience with electronic document management systems.
Excellent communication, problem-solving, and decision-making skills.
Proven ability to work independently, lead initiatives, and mentor junior staff.
$70,000 - $92,500 a year
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.
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We are seeking a
Quality Assurance Associate III
to join our team. This role is critical in scaling clinical production activities, ensuring compliance with cGMP and regulatory standards. The position involves batch record review, deviation investigations, label issuance, and management of controlled documentation across GLP/GCP/GMP systems. The ideal candidate is detail-oriented, organized, and passionate about driving quality excellence in a fast-paced environment.
Responsibilities
Lead batch record review and disposition for clinical product manufacturing, including label issuance, product packaging, and shipping activities.
Own deviation investigations and CAPA processes, ensuring timely resolution and compliance; author and approve associated reports.
Drive change control evaluations and oversee implementation of approved changes.
Manage controlled documentation within the GxP system (GLP/GCP/GMP), including issuing, tracking, distributing, and archiving records using electronic document management systems.
Develop and enhance quality management systems, including training programs, SOPs, and standards; provide guidance and mentorship to junior team members.
Coordinate and maintain controlled records (batch/test records, logbooks, validation documents, labels, reports, forms) for audits, training, equipment calibration, and preventive maintenance.
Author and approve policies, standards, procedures, and work instructions to ensure compliance and operational excellence.
Lead supplier quality activities, including qualification, monitoring, and performance reviews.
Oversee inventory database accuracy, including lot number tracking and timely updates; approve release of incoming materials.
Represent QA during regulatory inspections and internal audits, preparing and presenting relevant documentation.
Contribute to regulatory submission activities and ensure readiness for management and material review boards.
Champion continuous improvement initiatives across QA processes and systems.
Requirements
Bachelor’s degree in a scientific discipline (Life Sciences, Engineering, or related field).
3–5 years of progressive QA experience in a cGMP-regulated environment.
Demonstrated expertise in batch record disposition, deviation/CAPA management, and change control oversight.
Strong knowledge of FDA regulations (21 CFR Parts 210/211), ICH guidelines, and quality systems.
Ability to author and approve SOPs and quality documentation; experience with electronic document management systems.
Excellent communication, problem-solving, and decision-making skills.
Proven ability to work independently, lead initiatives, and mentor junior staff.
$70,000 - $92,500 a year
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.
#J-18808-Ljbffr