About the Role

The QA Associate will help ensure that life-changing biopharmaceutical products are manufactured to the highest standards. The QA Associate will provide day-to-day QA support across manufacturing, validation, materials, QC, engineering and facility operations at our Norton site, partnering with cross-functional teams to maintain GMP compliance and inspection readiness.


Key Responsibilities

• Provide raw material support, including review/approval of incoming material documentation and release for GMP use.


• Deliver on-the-floor QA support to manufacturing, including area clearance and changeover operations, ensuring readiness for production activities.


• Review and approve SOPs, master batch records (MBRs), specifications, risk assessments, and quality documents.


• Generate and maintain Quality-related SOPs and controlled forms.


• Review and approve validati...