Quality Systems Associate 2

Role Summary

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 document control, 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.

Responsibilities

• Support maintenance and continuous improvement of the Quality Management System (QMS) according to FDA, GMP, and ISO 9001 requirements
• Assist in document control activities, including creation, revision, routing, issuance, and archival of controlled documents
• Help manage and track corrective and preventive actions (CAPA) to ensure timely investigation, follow-up, and closure
• Assist in preparing for and conducting 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
• Assist with implementing and maintaining change control processes, ensuring proper documentation, review, and approval
• 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 administration of quality system software, including user access management, record maintenance, and troubleshooting
• Stay informed on evolving regulations, guidance documents, and industry best practices

Qualifications

• Required: Bachelor’s degree in Life Sciences, Engineering, or a related field
• Required: Minimum 2+ years of experience in quality systems, quality assurance, or quality operations within a regulated industry (pharmaceuticals, biologics, medical devices, etc.)
• Required: Knowledge of FDA regulations, GMP guidelines, and ISO 9001 standards
• Required: Strong attention to detail and organizational skills
• Required: Ability to work independently and collaboratively in a fast-paced environment
• Required: Proficiency in Microsoft Office (Word, Excel, PowerPoint)
• Required: Experience with QMS or electronic quality system software platforms
• Required: Strong written and verbal communication skills for effective cross-functional collaboration

Skills

• Required: Experience supporting audits, CAPA processes, deviations, or change control
• Preferred: Familiarity with electronic document management systems (EDMS) or commercial QMS tools
• Preferred: Experience in a GMP manufacturing, biologics, or cell therapy environment
• Preferred: Exposure to ISO audit practices or participation in internal audits
• Preferred: Ability to analyze quality data, produce reports, and identify trends

Education

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

Additional Requirements

• Primarily office-based, focusing on quality system management and documentation 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