- Salary
- $70k – $87k/yr
- Location
- San Diego, CA
- Workplace
- Onsite
- Type
- Full-time
- Department
- Capricor Therapeutics
- Seniority
- Entry
- Industry
- Biotechnology
- Category
- Healthcare
- Role type
- Individual Contributor
- Environment
- Clinical
- Source
- Lever
Overview
As a Quality Control Specialist at Capricor Therapeutics, you will support the development and testing of transformative cell and exosome-based therapies for rare diseases. The role involves ensuring product quality and compliance with regulatory standards. You'll work in a collaborative environment focused on advancing medical science and delivering life-changing treatments. The position requires a strong commitment to scientific excellence and attention to detail.
Description
Position Summary
The Quality Control Associate, Raw Materials is responsible for performing routine testing and documentation of raw materials used in Capricor’s manufacturing processes. This role ensures all incoming materials meet established specifications, regulatory requirements, and GMP standards.
As part of the QC Raw Materials team, you will perform hands‑on laboratory work, maintain accurate and compliant documentation, support investigations, and collaborate with QC, QA, Procurement, and Manufacturing teams to ensure timely material readiness. This is a new headcount created to support the expansion of Capricor’s manufacturing and quality operations.
Team Mission
The QC Raw Materials team ensures that all raw materials used in manufacturing consistently meet quality, safety, and regulatory standards. By verifying material identity, quality, and compliance, the team enables reliable production and supports Capricor’s broader mission of delivering high‑quality therapeutic products.
Responsibilities
-
Perform routine quality control testing of raw materials in accordance with approved specifications and SOPs.
-
Prepare samples, reagents, standards, and required materials for testing.
-
Accurately document all test results in laboratory notebooks, forms, and electronic systems following GMP and data integrity standards.
-
Identify, document, and report any out‑of‑specification (OOS), atypical, or questionable results to senior QC personnel.
-
Support investigations, deviations, and CAPA activities as assigned.
-
Maintain laboratory organization, cleanliness, and adherence to safety and GMP practices.
-
Assist with equipment operation, calibration, routine checks, and maintenance.
-
Follow all GMP, safety, and compliance procedures consistently.
-
Collaborate with QC, QA, Manufacturing, and Supply Chain groups to ensure timely material testing and release.
-
Participate in training, audits, and ongoing process improvement initiatives.
Skills
Languages
About Capricor Therapeutics
Capricor Therapeutics is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases.