Capricor Therapeutics, Inc. · 1 month ago
Quality Systems Associate 2
San Diego, CA
Full-time
Onsite
Entry Level
$75K/yr - $85K/yr
2+ years expCapricor Therapeutics is a biotechnology company focused on advancing cell and exosome-based therapies for rare diseases. The Quality Systems Associate will support and maintain the Quality Management System (QMS) to ensure compliance with various regulatory standards while collaborating with cross-functional teams to enhance quality operations.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Support maintenance and continuous improvement of the Quality Management System (QMS) according to FDA, GMP, and ISO 9001 requirements
Assist in document control activities, including creation, revision, routing, issuance, and archival of controlled documents
Help manage and track corrective and preventive actions (CAPA) to ensure timely investigation, follow‑up, and closure
Assist in preparing for and conducting internal audits; support readiness for external audits and inspections
Coordinate and track employee training activities to ensure staff remain compliant and current with required qualifications
Support management of deviations, non‑conformances, and audit findings, ensuring documentation is accurate and complete
Assist with implementing and maintaining change control processes, ensuring proper documentation, review, and approval
Collaborate with cross‑functional teams (QA, QC, Manufacturing, Facilities, R&D) to support quality system activities and improvements
Help generate, analyze, and maintain quality metrics and trend reports to support continuous improvement
Assist with administration of quality system software, including user access management, record maintenance, and troubleshooting
Stay informed on evolving regulations, guidance documents, and industry best practices
Qualification
Required
Bachelor's degree in Life Sciences, Engineering, or a related field
Minimum 2+ years of experience in quality systems, quality assurance, or quality operations within a regulated industry (pharmaceuticals, biologics, medical devices, etc.)
Knowledge of FDA regulations, GMP guidelines, and ISO 9001 standards
Strong attention to detail and organizational skills
Ability to work independently and collaboratively in a fast‑paced environment
Proficiency in Microsoft Office (Word, Excel, PowerPoint)
Experience with QMS or electronic quality system software platforms
Strong written and verbal communication skills for effective cross‑functional collaboration
Preferred
Experience supporting audits, CAPA processes, deviations, or change control
Familiarity with electronic document management systems (EDMS) or commercial QMS tools
Experience in a GMP manufacturing, biologics, or cell therapy environment
Exposure to ISO audit practices or participation in internal audits
Ability to analyze quality data, produce reports, and identify trends
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
Company data provided by crunchbase