Capricor Therapeutics, Inc. · 2 months ago
Quality Engineering Associate II
San Diego, CA
Full-time
Onsite
Entry Level
$80K/yr - $95K/yr
2+ years expCapricor Therapeutics is a biotechnology leader focused on developing biologics to impact patients' lives. The Quality Engineering Associate II will support operations and continuous improvement initiatives within the GMP facility, ensuring compliance with procedures and regulatory guidelines while contributing to quality excellence and process optimization.
BiotechnologyHealth CareMedicalTherapeutics
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
Qualification
Required
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)
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
Preferred certifications: ASQ Quality Engineering, Six Sigma Green/Black Belt
Experience with flow cytometry, functional assays, and DNA/RNA/protein analysis is a plus in broader R&D contexts
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
2026-01-09
MarketScreener
2025-12-17
Company data provided by crunchbase