Capricor Therapeutics, Inc. · 1 day ago
Supplier Quality Associate
San Diego, CA
Full-time
Hybrid
Mid Level
$70K/yr - $85K/yr
3+ years expCapricor Therapeutics is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. The Supplier Quality Associate is responsible for overseeing the development and maintenance of a robust supplier quality program, managing external audit programs, and ensuring compliance with Good Manufacturing Practice (GMP) standards.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Develop and Maintain Supplier Quality Program: Create, implement, and sustain a comprehensive supplier quality program to ensure consistent quality across the supply chain
Travel: Occasional travel may be required for supplier audits or vendor meetings
Create Supplier Scorecards: Develop and maintain scorecards to evaluate supplier performance and drive accountability
Ensure Audit Readiness: Maintain audit readiness and compliance with GMP and other regulatory standards
Conduct Supplier Qualifications and Audits: Perform supplier qualifications and risk-based audits to ensure supplier compliance and quality
Manage SCAR Activities: Oversee all supplier corrective action request (SCAR) processes, ensuring timely resolution of issues
Collaborate on Material Specifications: Work with cross-departmental teams to develop and refine material specifications
Prepare Quality Metrics: Compile and present quality metrics to stakeholders to support decision-making
Address Quality Issues: Partner with internal teams to resolve supplier quality and audit-related challenges
Drive Best Practices: Contribute to the development and implementation of best practices to enhance compliance and performance
Perform Data Analysis: Conduct data analysis and maintain organized records, reports, and databases to support quality processes
Implement Continuous Improvement: Recommend and implement measures to enhance quality processes and operational efficiency
Present Data Internally: Deliver data-driven insights to support decision-making and quality initiatives
Work Independently: Operate with minimal supervision to achieve project goals and meet deadlines
Review and Approve Documents: Review and approve assigned documents to ensure accuracy and compliance
Perform Additional Duties: Undertake other quality-related responsibilities as assigned to support organizational objectives
Qualification
Required
Bachelor's degree in a relevant Biological Science discipline required
3 years of experience in a GMP Quality Control laboratory or GMP/GLP setting required, with direct experience in Supplier Quality Management and corporate/supplier audits
3+ years of hands-on experience in qualifying suppliers and vendors, including risk assessments, capability evaluations, and ongoing performance monitoring
Experience managing Supplier Corrective Action Requests (SCARs), from initiation through closure, ensuring timely and effective resolution of quality issues
Skilled in drafting, revising, and maintaining SOPs to support quality system effectiveness and regulatory compliance
Excellent communication, time-management, and teamwork skills to collaborate effectively across departments
Strong organizational skills and attention to detail to manage records, reports, and databases
Ability to prioritize and manage multiple responsibilities in a fast-paced environment
Ability to gown and work in classified areas for audits or inspections
Ability to independently perform tasks, generate reports, and escalate issues as needed
Preferred
Experience conducting audits is a plus
Experience facilitating Supplier Quality Agreements is a plus
Proficiency in Outlook, MS Office, and eQMS is a plus
ASQ CQA certification preferred; candidates without current certification must demonstrate a willingness and ability to obtain certification within a specified timeframe
Strong team player with the ability to collaborate effectively across cross-functional departments
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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