Become a driving force in quality management at STEMCELL as a Senior Quality Assurance Associate. Your role is pivotal in ensuring products meet the highest quality and regulatory standards while driving process improvements.
In this role, you will perform vital QA activities, approve outputs, and maintain compliance with industry regulations. Your insights will contribute to our organization’s mission of quality and innovation, alongside a dedicated team within a collaborative environment.
Key Responsibilities:
• Maintain GMP cleanroom compliance and oversight
• Execute line clearances and resolve compliance issues
• Lead quality management system activities
• Review SOPs and ensure regulatory alignment
• Support continuous audit readiness and improvements
Requirements:
• Bachelor’s degree in related discipline
• Two years of QA experience in biotech preferred
• Familiarity with ISO 13485 and cGMP
• Strong critical thinking and organization skills