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About the Role
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
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...
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