Quality Assurance Specialist

We are seeking a Quality Assurance Specialist to strengthen and oversee our quality assurance development. You will pioneer and execute quality assurance activities associated with clinical Good Manufacturing Practices (GMP) of our bioprinted cell therapies. With a passion for optimization, you will also drive continuous improvement of our manufacturing and quality systems by developing, applying, revising, and maintaining quality metrics. 

Responsibilities 

• Support in development of internal QA processes and procedures and implementation of the company’s Quality Management System (QMS).
• Maintain and provide document control support.
• Assist in development of training content for QA processes, maintain training and certification requirements for the position. 
• Identify and evaluate issues and/or gaps in processes and documentation and propose effective solutions to remediate.
• Provide QA expertise on change management, and support implementation of documents, design, process, and material related changes. 
• Collaborate closely with R&D teams from the early development phases to embed quality standards directly into product designs, technical documentation, and underlying engineering processes 
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