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Senior Quality Assurance Associate

2 months ago

Denver, North Carolina, United States Biogen Full time
About the Role

We are seeking a highly motivated and detail-oriented Senior Quality Assurance Associate to join our team at Biogen. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our products.

Key Responsibilities
  • Review and approve GMP raw data for compliance and accuracy
  • Conduct thorough investigations of exceptions and CAPA to identify root causes and implement corrective actions
  • Develop and implement controlled document workflows to ensure compliance with regulations and company directives
  • Support the development and implementation of quality systems and system improvements
  • Collaborate with cross-functional teams to resolve technical and compliance issues
Requirements
  • Bachelor's degree in a field of science or biotechnology
  • Minimum of 4 years of relevant technical experience in quality oversight, preferably in a biotech or pharmaceutical manufacturing operation
  • General understanding of relevant FDA/EMA regulations and compliance
  • Strong organizational skills and attention to detail
Preferred Skills
  • Experience in downstream manufacturing operation
  • Experience with biologics
  • Experience in QC Microbiology
About Biogen

Biogen is a global biotechnology company committed to building on our culture of inclusion and belonging. We are dedicated to delivering life-changing medicines and improving the lives of patients worldwide. We are an equal opportunities employer and welcome applications from diverse candidates.