Quality Control Associate, Raw Materials

About Capricor Therapeutics

Capricor Therapeutics is a biotechnology company focused on developing innovative cell- and exosome-based treatments for rare diseases. Its lead program, Deramiocel (CAP-1002), is being advanced as a late-stage cell therapy for Duchenne muscular dystrophy. The company also uses its proprietary StealthX™ exosome platform to explore targeted delivery and vaccinology applications.

Role Overview

The Quality Control Associate, Raw Materials supports routine testing and documentation for raw materials used in manufacturing. The position plays a key role in confirming that incoming materials satisfy internal specifications, regulatory expectations, and GMP standards.

This is a hands-on laboratory role with a strong focus on accurate records, investigation support, and cross-functional coordination. The position works closely with QC, QA, Procurement, Manufacturing, and Supply Chain partners to help ensure materials are tested and available in a timely manner. This is a newly created headcount to support growth in Capricor’s manufacturing and quality functions.

Team Mission

The QC Raw Materials team helps verify that raw materials consistently meet quality, safety, and compliance requirements so manufacturing can proceed reliably. By confirming identity, quality, and regulatory readiness, the team supports the company’s mission to deliver high-quality therapies to patients and families.

Key Responsibilities

• Carry out routine QC testing of raw materials according to approved specifications and SOPs.
• Set up samples, reagents, standards, and other materials needed for testing.
• Record results accurately in notebooks, forms, and electronic systems while following GMP and data integrity expectations.
• Flag and escalate out-of-specification, unusual, or uncertain results to senior QC staff.
• Contribute to investigations, deviations, and CAPA work as needed.
• Keep the lab orderly, clean, and aligned with safety and GMP practices.
• Support equipment use, calibration, routine verification, and maintenance activities.
• Follow all applicable GMP, safety, and compliance procedures without exception.
• Work with QC, QA, Manufacturing, and Supply Chain teams to help ensure on-time testing and material release.
• Take part in training, audits, and continuous improvement efforts.

Minimum Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Biotechnology, or a related field is preferred; relevant experience may be accepted in place of formal education.
• Associate I level: some laboratory or QC exposure through academic or industry settings.
• Associate II level: at least 1 year of QC experience in a regulated environment such as pharma, biotech, or manufacturing.
• Strong attention to detail and the ability to work from SOPs and controlled procedures.
• Good grasp of basic lab techniques, reagent handling, and instrumentation.
• Strong documentation ability and comfort managing multiple samples and priorities efficiently.
• Familiarity with GMP or other regulated laboratory environments.

Preferred Qualifications

• Practical understanding of GMP, quality systems, and raw material workflows.
• Exposure to analytical methods such as FTIR, endotoxin testing, wet chemistry, or similar raw-material identification techniques.
• Experience using LIMS and Microsoft Office tools.
• Strong communication skills and the ability to collaborate effectively in a team setting.

Work Environment and Physical Requirements

• This is a laboratory-based position with regular work in GMP-controlled areas.
• Expect extended periods of computer-based work for documentation, analysis, and reporting.
• May require occasional lifting of materials or equipment weighing up to 20 pounds.
• Must be able to move through laboratory and manufacturing support areas for sampling, inspections, and oversight tasks.

Why Join Capricor

Capricor Therapeutics is committed to raising the standard of care through scientific innovation and patient-focused therapies. The company offers a collaborative environment where employees can grow professionally while contributing to meaningful advances in medicine.

Additional Information

Capricor does not conduct interviews or recruiting activity through Skype. Candidates will only be contacted from an official email address ending in @capricor.com. The company will never ask a candidate to send money or a check for any reason.

Notice to Recruiting Agencies

Capricor Therapeutics does not accept submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters unless there is prior written approval from Talent Acquisition management and a signed agreement in place. Unapproved outreach to hiring managers, business solicitation, or candidate submissions will not be considered. Any such submissions will be treated as the property of Capricor Therapeutics, and no placement fees will be paid for resulting hires.