Capricor Therapeutics, Inc. · 3 weeks ago
Quality Assurance Associate I
San Diego, CA
Full-time
Onsite
Entry Level
$65K/yr - $75K/yr
2+ years expCapricor Therapeutics is a biotechnology company focused on advancing cell and exosome-based therapies for rare diseases. The Quality Assurance Associate I will play a crucial role in supporting clinical product launch and production, including responsibilities such as batch record review, deviation investigation, and managing controlled documentation.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Support clinical product manufacturing by batch record review, label printing, product packaging, and shipping
Conduct or coordinate deviation investigations, corrective and preventative actions (CAPA), change controls, company-wide training, and internal audits. Write associated reports
Process controlled documentation through the GxP (GLP / GCP / GMP) documentation system, including but not limited to word processing, tracking, issuing, distributing, and archiving, utilizing manual or an electronic document management system
Coordinate / track / archive: controlled records (i.e., batch / test records, logbooks, validation documents, labels, reports, forms, etc) for change controls, deviations, CAPAs, audits, training, equipment calibration and preventative maintenance
Write and/or review policies, standards, procedures and work instructions to document Quality documentation processes and practices
Support supplier and material management, including ordering, incoming receipt, record keeping etc
Perform review and release of incoming materials
Inventory database management including accurate and timely updating of lot numbers and quantities
Collaborate on development / improvement and implementation of material, facility and quality management systems
Other required duties as may be assigned
Qualification
Required
Bachelor's Degree and 2+ years of experience in a cGMP environment
Knowledge of standard processes involved in document control and experience in an FDA regulated environment
Experience in Aseptic Processing a plus
Precise attention to detail
Excellent record keeping skills
Strong, demonstrable computer skills in MS Word, Excel, Visio, Access; Adobe suite; and database systems
Familiar with Quality Systems and records management in a cGMP environment
Strong communication and problem-solving skills
Results oriented with dedication to compliance and customer service
Strong initiative and follow-through
Comfortable working in a fast paced and dynamic environment
Ability to gown and work in a classified area as required
Must be able to sit and stand for extended periods
Must be able to lift/carry reports and materials up to 40 pounds, move about the office, communicate efficiently and effectively on the telephone or in person, and complete required paperwork
Benefits
Comprehensive benefits package, including health insurance
Retirement plans
Opportunities for professional development
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