Capricor Therapeutics, Inc. · 2 months ago
Quality Engineering Associate III - CQV
San Diego, CA
Full-time
Onsite
Mid, Senior Level
$92K/yr - $114K/yr
3+ years expCapricor Therapeutics is a biotechnology leader focused on developing innovative biologics to improve patients' lives. They are seeking a Quality Engineer III to lead CQV activities and ensure compliance in their GMP facility in San Diego while driving continuous improvement initiatives.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Lead CQV activities for equipment and facilities in alignment with Capricor procedures and regulatory standards
Author and approve validation protocols, reports, and related documentation
Collaborate with Manufacturing, Facilities, Safety, and Quality teams to maintain compliance and operational efficiency
Drive process improvements and implement best practices across quality systems
Review calibration, preventive maintenance, and service reports for GMP equipment and facilities
Provide technical assessments and evaluations within the change control process
Conduct risk assessments using tools such as FMEA, Risk Matrix, and Decision Trees
Oversee vendor qualification and compliance audits; prepare technical and investigation reports as needed
Support internal and external audits, including regulatory inspections
Track and report key quality metrics to inform continuous improvement initiatives
Lead quality-related projects and mentor junior team members
Perform additional duties as required
Qualification
Required
Bachelor's degree in a scientific or engineering discipline and 3+ years of experience in a pharmaceutical or FDA-regulated environment
Minimum of 3 years in Quality Engineering or validation within a GMP setting (Drug Substance or Drug Product)
Strong knowledge of CQV principles and quality systems
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
Experience leading greenfield or brownfield facility buildouts preferred
Familiarity with regulatory requirements (21 CFR Parts 11, 210, 211; ICH Q8–Q10)
Preferred certifications: ASQ Quality Engineering, Six Sigma Green/Black Belt
Company
Capricor Therapeutics, Inc.
Capricor Therapeutics is a publicly traded (NASDAQ: CAPR) biotechnology company with a mission to develop groundbreaking therapies that make a meaningful impact on patients’ lives.
51-200 employees
H1B Sponsorship
Capricor Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$329.5MKey Investors
Nippon ShinyakuNational Institutes of HealthCalifornia Institute for Regenerative Medicine
2025-12-05Post Ipo Equity· $150M
2024-10-17Post Ipo Equity· $75M
2024-09-17Post Ipo Equity· $15M
Leadership Team
AJ Bergmann
Chief Financial Officer
Recent News
MarketScreener
2025-12-17
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2025-12-09
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