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Sr. Associate I, Quality Engineering
Company Name: Biogen
Job Overview
The Sr. Associate I, Quality Engineering at Biogen oversees Quality Assurance functions at the Research Triangle Park facility, providing quality oversight for Engineering, Manufacturing, Maintenance, and Facilities teams to ensure cGMP compliance.
Responsibilities
- Reviewing and approving lifecycle documentation
- Managing changes
- Providing cGMP guidance
- Supporting investigations and CAPAs
- Driving continuous improvement
Requirements
- Bachelor's degree in a relevant field
- 4+ years of experience
- Knowledge of regulatory guidelines (FDA/EMA, cGMPs, ICH)
- Expertise in Quality Engineering Systems