Quality Systems Associate 2 - Training

San DiegoFull-time (exempt)mid

OtherQuality Systems

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Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases.

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OtherQuality Systems

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.

The Quality Systems Associate will support and maintain Capricor’s Quality Management System (QMS) to ensure compliance with FDA, GMP, ISO 9001, and internal quality standards. This role will assist in training, audit preparation, quality records management, and system administration while collaborating across functional teams to strengthen Capricor’s quality operations.

This is an excellent opportunity for someone who is detail‑oriented, organized, and eager to grow their quality career in a fast‑paced biotech environment.

Support maintenance and continuous improvement of the Quality Management System (QMS) according to FDA, GMP, and ISO 9001 requirements.

Create and update training materials, including SOP-based training modules, curricula, and assessments.

Oversee onboarding and continuous training programs for new and existing employees.

Generate routine training compliance reports and escalate gaps to management.

Assist in preparing for internal audits; support readiness for external audits and inspections.

Coordinate and track employee training activities to ensure staff remain compliant and current with required qualifications.

Support management of deviations, non conformances, and audit findings, ensuring documentation is accurate and complete.

Collaborate with cross functional teams (QA, QC, Manufacturing, Facilities, R&D) to support quality system activities and improvements.

Help generate, analyze, and maintain quality metrics and trend reports to support continuous improvement.

Assist with the administration of quality system software, including user access management, record maintenance, and troubleshooting.

Stay informed on evolving regulations, guidance documents, and industry best practices.

Perform other duties and responsibilities as assigned to support departmental and organizational objectives.

Bachelor’s degree in Life Sciences, Engineering, or a related field.

Minimum 3+ years of experience in quality systems, quality assurance, or quality operations within a regulated industry (pharmaceuticals, biologics, medical devices, etc.).

Knowledge of FDA regulations, GMP guidelines, and ISO 9001 standards.

Proven experience creating and updating training materials, including SOP-based training modules, curricula, and assessments.

Oversee onboarding and continuous training programs for new and existing employees.

Generate routine training compliance reports and escalate gaps to management.

Ability to work independently and collaboratively in a fast paced environment.

Proficiency in Microsoft Office (Word, Excel, PowerPoint).

Experience with QMS or electronic quality system software platforms (QT9/Veeva preferred).

Strong written and verbal communication skills for effective cross functional collaboration.

• Experience in a GMP manufacturing, biologics, or cell therapy environment.
• Exposure to ISO audit practices or participation in internal audits.
• Ability to analyze quality data, produce reports, and identify trends.

• Primarily office based, focusing on quality system management and training activities.
• Requires prolonged periods of computer use for documentation, reporting, and system administration.
• Occasional lifting of office materials up to 15 pounds.
• Ability to move between office and operational areas to support audits and cross functional work.