Sr Associate Ii, Quality Assurance Operations

Biogen

Research Triangle Park, NC, United States
Base: $93,000.00-$121,000.00; bonus/equity: cash b...
Quality management systems oversight
Cgmp compliance
Batch record review
The Sr. Associate II is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility

Job Summary

  • The Sr. Associate II is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility.
  • This individual will assist with regulatory and third party audits, aid in the development and implementation of Global Quality Systems, and manage Quality projects and other initiatives.
  • Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being.

Matching Summary

The Sr. Associate II is responsible for the oversight of key strategic, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility.

Salary

Base: $93,000.00-$121,000.00; Bonus/Equity: Cash bonus and equity incentive opportunities; Benefits: Medical, Dental, Vision, Life, Disability, 401(k) match, tuition reimbursement

Skills & Requirements

Must-have

  • Quality Management Systems oversight
  • cGMP compliance
  • Batch Record Review
  • Exception and CAPA assessment
  • Controlled Document Workflows
  • Regulatory compliance guidance

Nice-to-have

  • Continuous improvement focus
  • Curious and eager to learn
  • Excellent communication and collaboration
  • Logical thinking and problem solving

Key Requirements

  • Bachelor’s Degree in life science or Associate's Degree plus 7+ years experience
  • Minimum 5 years QA experience in GMP pharma/biotech
  • Experience reviewing batch records, SOPs
  • Experience conducting investigations
  • Experience working in manufacturing environment
  • Advanced understanding of GxP regulations

Work Rights

Not specified

Tailored Resume

Cover Letter