QA Associate Quality Operations
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 validation documents and protocol executions to confirm compliance with approved procedures and regulatory requirements.
- Review and approve QC laboratory qualification documents, including equipment qualification.
- Perform executed batch record review and approval to ensure accuracy and compliance.
- Review and approve deviations, CAPAs, Change Controls and related investigations in the quality management system.
- Support partner audits and regulatory inspections, including document retrieval and subject matter input.
- Approve work orders in the maintenance system to verify equipment maintenance and calibration compliance.
- Collaborate with internal cross-functional teams at the Norton facility to drive continuous improvement and quality excellence.
- Bachelor s degree in a scientific or engineering discipline (Biology, Chemistry, Biotechnology, etc.) or equivalent experience.
- 2 4 years of GMP experience in Quality, Manufacturing, or QC.
- Knowledge of cGMP regulations (21 CFR Parts 210/211/11, ICH Q7/Q10) and Good Documentation Practices.
- Strong attention to detail, organizational skills, and the ability to communicate effectively across teams.
- Experience with quality systems (e.g., Veeva, SAP) is a plus.
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