What are the responsibilities and job description for the Quality Assurance Specialist position at beBee Careers?
About the Role
We are seeking a highly skilled Quality Assurance specialist to join our team. As a Senior Associate, Quality Assurance for Manufacturing, you will be responsible for ensuring the quality and compliance of our products.
Key Responsibilities:
- Provide quality oversight to ensure CGMP requirements are met for Clinical and Commercial material.
- Independently perform and manage batch record review activities for production.
- Support Out of Specification/Trend investigations.
- Serve as quality contact and support for minor deviations, CAPA implementation, change control records, or other quality records, as needed.
Requirements:
- Experience in manufacturing operations and quality assurance/quality control in a cell therapy company (preferred).
- Knowledgeable of aseptic techniques and clean room practices.
- Experience with USP and EP compendial testing.
- Strong understanding of Quality Management Systems: deviations, CAPA, Change control.
