Quality Assurance Associate - Raw Materials

Job Description

Job DescriptionAbout Capricor Therapeutics

Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a cutting-edge biotechnology company focused on the discovery and development of novel therapies for the treatment or prevention of rare diseases. Our lead product candidate, allogeneic Cardiosphere-Derived Cells (CDCs), known as CAP-1002, is being investigated as a treatment for Duchenne muscular dystrophy. Additionally, we are advancing our exosomes platform technology for inflammatory indications and developing a novel vaccination approach against COVID-19. Capricor is undergoing a manufacturing technology transfer to produce CAP-1002 for late-stage clinical trials and establish a commercial-scale process, while also developing manufacturing processes for exosome-based vaccines. Join our expanding team to contribute to transformative therapies that address unmet medical needs.

Position Overview

The Quality Assurance Raw Materials Associate I is responsible for reviewing, inspecting, and evaluating all material receipts at Capricor to ensure compliance with established procedures and GMP manufacturing specifications. Reporting to the Quality Assurance leadership, this role involves real-time documentation, identifying and escalating quality issues, and fostering a quality-driven mindset in a collaborative environment. The ideal candidate is a highly motivated individual capable of independent work, with strong communication, analytical, and documentation skills. This position plays a critical role in supporting Capricor’s commitment to quality in the production of innovative therapies for rare diseases.

Responsibilities

• Evaluate Material Receipts: Assess material receipt packages in accordance with approved procedures to ensure compliance.

• Execute Real-Time Documentation: Perform accurate documentation during the material inspection process, adhering to good documentation practices.

• Ensure Specification Compliance: Verify that inspections are conducted according to approved material specifications and execute transactions in the ERP system as required.

• Work Independently: Operate with minimal supervision to complete assigned tasks and meet project goals.

• Identify and Escalate Issues: Detect and escalate deviations or other quality events promptly to ensure compliance.

• Propose Process Improvements: Identify opportunities for process enhancements to improve efficiency and quality.

• Make Real-Time Quality Decisions: Apply regulations and procedures to make informed quality decisions during inspections.

• Collaborate Cross-Functionally: Work with cross-functional teams to meet scheduled timelines and support manufacturing goals.

• Support Material Disposition: Facilitate documentation to support material disposition decisions post-inspection.

• Communicate Effectively: Demonstrate excellent communication skills with internal and external customers, supervisors, and colleagues.

• Uphold Ethical Standards: Operate with the highest ethical and moral standards in all activities.

• Contribute as a Team Player: Participate effectively in all aspects of Capricor’s business, fostering a collaborative environment.

• Adhere to Quality Standards: Follow regulations, Capricor policies, procedures, and mission to maintain quality standards.

• Adapt to Dynamic Environment: Thrive in a fast-paced, agile work environment with flexibility as needed.

• Support Operations: Provide support to QA Operations, Supply Chain, and Manufacturing Operations as required.

• Perform Additional Duties: Undertake other quality-related responsibilities as assigned to support organizational objectives.

Requirements

• Education: Degree in a relevant discipline (e.g., microbiology, chemistry, biological sciences, bioengineering, etc.).

• Experience: 1-2 years of experience in Quality Assurance and Raw Material inspection in a GMP facility or equivalent experience.

• Technical Skills: Proficiency in Outlook, MS Office, and other applicable electronic systems; knowledge of GMP regulations and processes.

• Communication and Teamwork: Excellent communication, time-management, and teamwork skills to collaborate effectively in a dynamic environment.

• Independent Work: Ability to independently perform assigned tasks, generate reports, and escalate issues as needed.

• Attention to Detail: Strong documentation skills to ensure compliance with good documentation practices.

Work Environment and Physical Demands

• Setting: Primarily laboratory- and office-based, focusing on material inspection, documentation, and quality assurance activities.

• Physical Requirements: Ability to stand for 1-2 hours and sit for 2-3 hours at a time; frequently lift or move objects up to 25 pounds; use arms, hands, and fingers to handle, feel, or reach; ability to climb, balance, stoop, kneel, or crouch as needed.

Why Capricor?

Capricor Therapeutics is an industry leader in cell and exosome therapy, pushing boundaries to create innovative treatments that raise the standard of care. Grounded in integrity and driven by science, our team is committed to making a meaningful impact through patient-centered innovation. Join us and be part of a team that’s changing lives—help us shape the future of healthcare.

Compensation (USD)

• Salary Range: Competitive, commensurate with experience.

• Benefits: Comprehensive benefits package, including health insurance, retirement plans, equity awards, and opportunities for professional development.

Come Work with Us!

At Capricor, we offer a collaborative work environment that supports your professional growth. Join a passionate team committed to transforming the lives of patients and pushing the boundaries of medical science.