Capricor Therapeutics, Inc. · 2 months ago
Quality Assurance Associate II/III
San Diego, CA
Full-time
Onsite
Mid, Senior Level
$70K/yr - $92K/yr
3+ years expCapricor Therapeutics is a biotechnology leader focused on developing groundbreaking biologics. The Quality Assurance Associate III role is critical for ensuring compliance with cGMP and regulatory standards, involving batch record review, deviation investigations, and management of controlled documentation.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Lead batch record review and disposition for clinical product manufacturing, including label issuance, product packaging, and shipping activities
Own deviation investigations and CAPA processes, ensuring timely resolution and compliance; author and approve associated reports
Drive change control evaluations and oversee implementation of approved changes
Manage controlled documentation within the GxP system (GLP/GCP/GMP), including issuing, tracking, distributing, and archiving records using electronic document management systems
Develop and enhance quality management systems, including training programs, SOPs, and standards; provide guidance and mentorship to junior team members
Coordinate and maintain controlled records (batch/test records, logbooks, validation documents, labels, reports, forms) for audits, training, equipment calibration, and preventive maintenance
Author and approve policies, standards, procedures, and work instructions to ensure compliance and operational excellence
Lead supplier quality activities, including qualification, monitoring, and performance reviews
Oversee inventory database accuracy, including lot number tracking and timely updates; approve release of incoming materials
Represent QA during regulatory inspections and internal audits, preparing and presenting relevant documentation
Contribute to regulatory submission activities and ensure readiness for management and material review boards
Champion continuous improvement initiatives across QA processes and systems
Qualification
Required
Bachelor's degree in a scientific discipline (Life Sciences, Engineering, or related field)
3–5 years of progressive QA experience in a cGMP-regulated environment
Demonstrated expertise in batch record disposition, deviation/CAPA management, and change control oversight
Strong knowledge of FDA regulations (21 CFR Parts 210/211), ICH guidelines, and quality systems
Ability to author and approve SOPs and quality documentation; experience with electronic document management systems
Excellent communication, problem-solving, and decision-making skills
Proven ability to work independently, lead initiatives, and mentor junior staff
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