Capricor Therapeutics, Inc.
Quality Engineering Associate II
Capricor Therapeutics, Inc., San Diego, California, United States, 92189
Overview
Join to apply for the
Quality Engineering Associate II
role at
Capricor Therapeutics, Inc. Capricor Therapeutics, Inc. provided pay range. This range is provided by Capricor Therapeutics, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$80,000.00/yr - $95,000.00/yr 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. 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
Experience with flow cytometry, functional assays, and DNA/RNA/protein analysis is a plus in broader R&D contexts 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. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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Join to apply for the
Quality Engineering Associate II
role at
Capricor Therapeutics, Inc. Capricor Therapeutics, Inc. provided pay range. This range is provided by Capricor Therapeutics, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$80,000.00/yr - $95,000.00/yr 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. 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
Experience with flow cytometry, functional assays, and DNA/RNA/protein analysis is a plus in broader R&D contexts 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. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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