Capricor Therapeutics, Inc. · 2 months ago
Quality Assurance Associate I/ II
San Diego, CA
Full-time
Onsite
New Grad, Entry Level
$70K/yr - $82K/yr
0+ years expCapricor Therapeutics is a biotechnology company dedicated to advancing transformative therapies for rare diseases. They are seeking a Quality Assurance Associate I/II to assist in ensuring compliance with cGMP and regulatory standards while supporting clinical production activities.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Assist in batch record review and disposition for clinical product manufacturing, including label issuance, product packaging, and shipping activities
Support the issuance, tracking, and archiving of controlled documentation in compliance with GxP (GLP/GCP/GMP) regulations
Maintain and manage controlled records, including batch/test records, logs, reports, and quality management documentation
Assist in preparing materials for internal audits and ensuring documentation readiness for regulatory inspections
Help process and track training records to ensure company-wide GxP compliance
Participate in the review and release of incoming materials in accordance with company standards
Support controlled label issuance, including inventory tracking and updating lot numbers
Collaborate with senior team members to improve and implement quality management systems and training programs
Assist in preparing reports and documentation related to deviations, corrective actions, and change controls
Support the maintenance and management of documentation systems, both manual and electronic, ensuring timely and accurate record-keeping
Perform additional quality assurance tasks as assigned
Qualification
Required
Bachelor's degree in a relevant field (e.g., Biology, Biotechnology, or related discipline) or equivalent experience
0-3 years of experience in a regulated environment (e.g., cGMP, GLP, GCP)
Strong attention to detail and excellent organizational skills for managing documentation and records
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with database systems
Strong written and verbal communication skills for effective collaboration and reporting
Ability to work independently and as part of a team in a dynamic, fast-paced environment
Comfortable gowning and working in classified areas as required
Preferred
Familiarity with regulatory standards such as 21 CFR 210 and 211, ICH, ISO9001, and FDA guidelines preferred
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