Capricor Therapeutics, Inc.
Quality Assurance Associate I
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 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.
$65,000 - $75,000 a year
Comprehensive benefits package, including health insurance, retirement plans, and opportunities for professional development.
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
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 a plus
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.
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 is an industry leader in cell and exosome therapy, pushing boundaries to create innovative treatments that raise the standard of care. Grounded in integrity and driven by science, our team is committed to making a meaningful impact through patient-centered innovation. Join us and be part of a team that’s changing lives—help us shape the future of healthcare.
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
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.
$65,000 - $75,000 a year
Comprehensive benefits package, including health insurance, retirement plans, and opportunities for professional development.
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
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 a plus
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.
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 is an industry leader in cell and exosome therapy, pushing boundaries to create innovative treatments that raise the standard of care. Grounded in integrity and driven by science, our team is committed to making a meaningful impact through patient-centered innovation. Join us and be part of a team that’s changing lives—help us shape the future of healthcare.
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