I have an exclusive opportunity for a Senior QA Associate to join a pioneering biotechnology company based in Stevenage that focuses on developing T-cell therapies for cancer treatment.

They seek a Senior QA Associate with GMP experience to support their manufacturing site and ensure compliance with regulatory requirements for clinical trial manufacture. You will support the Quality Management System, review and approve documentation, investigate quality issues, and conduct audits.

This role will offer you:

• A permanent position in a senior QA position within a breakthrough CGT company offering a competitive package
• Work in a fast-paced, innovative environment

You will be responsible for:

• Performing and supporting Quality Assurance duties at a manufacturing site for the company's Investigational Medicinal Product (IMP)
• Perform QA review and approval of procedures, master batch records, and any other relevant cGMP documentation
• Supporting the administration of the Quality Management System (QMS)
• Perform internal and external audits, support the hosting of customer audits and regulatory inspections, and assist senior management with the coordination of recall activities

You will bring the following:

• A thorough understanding of GMP requirements
• Must have experience working with ATMP and CGT
• Minimum 3 years exp in a QA position
• Technical knowledge of Aseptic, Sterile, and Laboratory techniques