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Capricor Therapeutics

Posted 7 months ago

Open

Quality Assurance Associate II

San DiegoOn-siteFull-time

AI Summary

Quality Assurance Associate II is responsible for supporting batch record review, deviation investigations, document control, and regulatory readiness in a cGMP environment.

About this role

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.

We are seeking a Quality Assurance Associate II to join our team. This role is critical in scaling clinical production activities, ensuring compliance with cGMP and regulatory standards. The position will assist in batch record review, deviation investigations, label issuance, and management of controlled documentation across GLP/GCP/GMP systems. The ideal candidate is detail-oriented, organized, and passionate about driving quality excellence in a fast-paced environment.

Responsibilities

  • Assist in batch record review and disposition for clinical product manufacturing, including label issuance, product packaging, and shipping activities.
  • Support the issuance, tracking, and archiving of controlled documentation in compliance with GxP (GLP/GCP/GMP) regulations.
  • Maintain and manage controlled records, including batch/test records, logs, reports, and quality management documentation.
  • Assist in preparing materials for internal audits and ensuring documentation readiness for regulatory inspections.
  • Help process and track training records to ensure company-wide GxP compliance.
  • Participate in the review and release of incoming materials in accordance with company standards.
  • Support controlled label issuance, including inventory tracking and updating lot numbers.
  • Collaborate with senior team members to improve and implement quality management systems and training programs.
  • Assist in preparing reports and documentation related to deviations, corrective actions, and change controls.
  • Support the maintenance and management of documentation systems, both manual and electronic, ensuring timely and accurate record-keeping.
  • Perform additional quality assurance tasks as assigned.

    • Requirements

  • 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).
  • Familiarity with regulatory standards such as 21 CFR 210 and 211, ICH, ISO9001, and FDA guidelines preferred.
  • 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.
  • 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.

    • Work Environment / Physical Demands

  • Primarily office-based with occasional time in GMP cleanroom environments for documentation and oversight tasks.
  • Requires prolonged periods of computer use for documentation and record management, and gowning for cleanroom work.
  • May involve lifting materials or equipment up to 20 pounds.
  • Ability to navigate office and classified GMP environments for quality assurance activities.

    • Skills

    AuditsBatch Record ReviewCAPAChange ControlsData IntegrityDeviation InvestigationsDocumentation ManagementElectronic Document Management SystemsGCPGLPGMPGowningGxPInventory TrackingIQ/OQ/PQLabel IssuanceMaterial ReleaseMS OfficeQuality Management SystemsTraining Records

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