Capricor Therapeutics, Inc. · 1 month ago
Quality Assurance Associate I – Document Control
San Diego, CA
Full-time
Onsite
Entry Level
$65K/yr - $75K/yr
1+ years expCapricor Therapeutics is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. They are seeking a highly organized Quality Assurance Associate I to manage document control processes, ensuring compliance and efficiency in clinical manufacturing operations.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Coordinate, track, issue, reconcile, and archive controlled records including executed batch records, logbooks, QC test records, validation documents, labels, forms, training records, equipment calibration/preventive maintenance records, deviation/CAPA documentation, and audit files
Issue blank controlled batch records, logbooks, labels, and forms to Manufacturing and QC; receive, review for completeness, and file executed versions
Scan, upload, index, and maintain electronic records; organize and retrieve physical archives to ensure immediate availability for audits and inspections
Track document change controls, periodic reviews, training requirements, and record retention schedules; follow up to keep all activities current
Remove and destroy obsolete documents/records from all points of use
Generate and maintain document control trackers, overdue lists, and status reports
Occasionally draft, format, or revise document-control-specific procedures, forms, and work instructions
Provide rapid, accurate record retrieval and document packages during internal audits, vendor audits, and regulatory inspections
Support batch record review, label issuance, and basic raw material receipt/documentation as needed
Other duties as assigned in direct support of document control and records management
Qualification
Required
Bachelor's Degree (life sciences preferred) and 1–3 years of document control or records management experience in a cGMP environment (strong internships or co-ops considered)
Solid knowledge of Good Documentation Practices (GDP) and basic document control processes in an FDA-regulated environment
Precise attention to detail with outstanding organizational and record-keeping skills
Strong computer skills in MS Word, Excel, Adobe Acrobat; experience with SharePoint or basic electronic systems a plus
Familiar with controlled records management in a cGMP environment
Excellent follow-through and ability to manage multiple concurrent tasks and deadlines
Results-oriented with dedication to accuracy and compliance
Strong initiative and comfortable working in a fast-paced, dynamic environment
Ability to gown and enter classified areas as required to deliver/retrieve records
Preferred
Experience in aseptic processing or cell therapy environments
Exposure to Veeva Vault or similar EQMS
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
MarketScreener
2025-12-17
Genetic Engineering News
2025-12-09
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