Quality Assurance Associate II – Capricor Therapeutics, Inc. – Jobs in San Diego, CA | OpenJobs AI

Job Details

Overview Company

Quality Assurance Associate II

$70305/y-$82000/y

Capricor Therapeutics, Inc.

2 days ago

Highlight

OnsiteFull-timeEntry

Summary

Capricor Therapeutics, Inc. is seeking a Quality Assurance Associate II to join their team in San Diego, CA. The role is critical in scaling clinical production activities and ensuring compliance with cGMP and regulatory standards.

About the Role

As a Quality Assurance Associate II, you will assist in batch record review, deviation investigations, label issuance, and management of controlled documentation across GLP/GCP/GMP systems. Your responsibilities will include maintaining controlled records, preparing for internal audits, processing training records, and collaborating with senior team members to improve quality management systems.

About You

Required:

Bachelor’s degree in a relevant field (e.g., Biology, Biotechnology, or related discipline) or equivalent experience.
0-3 years of experience in a regulated environment (e.g., cGMP, GLP, GCP).
Strong attention to detail and excellent organizational skills for managing documentation and records.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with database systems.
Strong written and verbal communication skills for effective collaboration and reporting.

Preferred:

Familiarity with regulatory standards such as 21 CFR 210 and 211, ICH, ISO9001, and FDA guidelines.
Ability to work independently and as part of a team in a dynamic, fast-paced environment.
Comfortable gowning and working in classified areas as required.

Benefits

Collaborative environment that nurtures professional growth and innovation.
Opportunity to contribute to a mission-driven group transforming lives with innovative therapies.

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. Capricor is focused on the development of biologics, primarily cell and exosome-based technologies to treat or prevent a broad range of diseases. Our lead product is a cell therapy designed to treat Duchenne muscular dystrophy (DMD), the most severe form of muscular dystrophy, which results in muscle degeneration and premature death. Capricor’s innovative exosome technology is focusing on engineering exosomes to treat or prevent diseases with high unmet medical needs. Our translational approach to product development is based on the strong research foundation provided by our academic partnerships with leading scientists at top-tier research institutions.

San Diego, CA