Capricor Therapeutics, Inc.
Quality Engineering Associate II
Capricor Therapeutics, Inc., 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. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.
We are seeking a Quality Engineering Associate II to join our growing team. This role will support operations and continuous improvement initiatives for Capricor’s GMP facility. The position ensures compliance with internal procedures and regulatory guidelines while contributing to process optimization and quality excellence. In practice, this means applying quality engineering principles to monitor and improve equipment and facility performance, reviewing maintenance and calibration records, and supporting risk assessments and change control processes. You will also play a key role in vendor qualification, audit readiness, and implementing corrective and preventive actions (CAPA) to maintain a robust quality management system.
Responsibilities
Collaborate with R&D, operations, and other site functions, including Manufacturing, Facilities, Safety, and Quality
Identify process improvements and recommend changes
Review calibration, preventive maintenance, and service reports for equipment and facilities
Provide quality support for technical assessments and evaluations within the change control process
Prepare reports and documentation related to equipment, facilities, and maintenance activities
Ensure alignment of equipment/facilities and IT system qualifications with Capricor procedures
Support regulatory inspections and audits
Conduct risk assessments using tools such as FMEA, Risk Matrix, and Decision Trees
Assist with vendor qualification and compliance audits; prepare technical and investigation reports as needed
Track and report quality metrics to drive continuous improvement
Contribute to quality-related projects and initiatives within the R&D organization
Perform additional duties as required
Requirements
Bachelor’s degree in a scientific or engineering discipline and 2+ years of experience in a pharmaceutical or FDA-regulated environment
Minimum of 2 years in Quality Engineering or validation within a GMP setting (Drug Substance or Drug Product)
Strong knowledge of quality systems and regulatory requirements (21 CFR Parts 11, 210, 211; ICH Q8–Q10)
Preferred certifications: ASQ Quality Engineering, Six Sigma Green/Black Belt
Familiarity with GMPs, Health Authority regulations, and validation principles
Understanding of audit principles and quality assurance practices
Proficiency in Microsoft Word, Excel, PowerPoint, and related applications
Excellent written and verbal communication skills
Ability to work independently and collaborate effectively with technical teams
Preferred Qualifications (Nice to Have)
Experience with flow cytometry, functional assays, and DNA/RNA/protein analysis is a plus in broader R&D contexts
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We are seeking a Quality Engineering Associate II to join our growing team. This role will support operations and continuous improvement initiatives for Capricor’s GMP facility. The position ensures compliance with internal procedures and regulatory guidelines while contributing to process optimization and quality excellence. In practice, this means applying quality engineering principles to monitor and improve equipment and facility performance, reviewing maintenance and calibration records, and supporting risk assessments and change control processes. You will also play a key role in vendor qualification, audit readiness, and implementing corrective and preventive actions (CAPA) to maintain a robust quality management system.
Responsibilities
Collaborate with R&D, operations, and other site functions, including Manufacturing, Facilities, Safety, and Quality
Identify process improvements and recommend changes
Review calibration, preventive maintenance, and service reports for equipment and facilities
Provide quality support for technical assessments and evaluations within the change control process
Prepare reports and documentation related to equipment, facilities, and maintenance activities
Ensure alignment of equipment/facilities and IT system qualifications with Capricor procedures
Support regulatory inspections and audits
Conduct risk assessments using tools such as FMEA, Risk Matrix, and Decision Trees
Assist with vendor qualification and compliance audits; prepare technical and investigation reports as needed
Track and report quality metrics to drive continuous improvement
Contribute to quality-related projects and initiatives within the R&D organization
Perform additional duties as required
Requirements
Bachelor’s degree in a scientific or engineering discipline and 2+ years of experience in a pharmaceutical or FDA-regulated environment
Minimum of 2 years in Quality Engineering or validation within a GMP setting (Drug Substance or Drug Product)
Strong knowledge of quality systems and regulatory requirements (21 CFR Parts 11, 210, 211; ICH Q8–Q10)
Preferred certifications: ASQ Quality Engineering, Six Sigma Green/Black Belt
Familiarity with GMPs, Health Authority regulations, and validation principles
Understanding of audit principles and quality assurance practices
Proficiency in Microsoft Word, Excel, PowerPoint, and related applications
Excellent written and verbal communication skills
Ability to work independently and collaborate effectively with technical teams
Preferred Qualifications (Nice to Have)
Experience with flow cytometry, functional assays, and DNA/RNA/protein analysis is a plus in broader R&D contexts
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