Sr Associate Ii, Quality Assurance Operations

Biogen

Research Triangle Park, NC, United States
Base: $93,000.00-$121,000.00; bonus/equity: cash b...
Batch record review and disposition
Regulatory compliance with fda/ema
Quality project management
As a Sr. Associate II in Quality Assurance, you will oversee the quality strategy for assigned programs and manufacturing operations at the RTP PHARMA site

Job Summary

  • As a Sr. Associate II in Quality Assurance, you will oversee the quality strategy for assigned programs and manufacturing operations at the RTP PHARMA site.
  • Biogen offers a highly competitive benefits package including medical, dental, vision, life insurance, paid vacation, holidays, parental leave, 401(k) with company match, and tuition reimbursement.
  • The company fosters a culture of inclusion and belonging, emphasizing diversity and employee empowerment to drive innovation and excellence.

Matching Summary

As a Sr. Associate II in Quality Assurance, you will oversee the quality strategy for assigned programs and manufacturing operations at the RTP PHARMA site.

Salary

Base: $93,000.00-$121,000.00; Bonus/Equity: Cash bonus and equity incentives available; Benefits: Comprehensive benefits including insurance, paid time off, 401(k), and tuition reimbursement

Skills & Requirements

Must-have

  • Batch record review and disposition
  • Regulatory compliance with FDA/EMA
  • Quality project management
  • cGMP standards adherence
  • Investigations and change controls
  • Quality document review and approval

Nice-to-have

  • Mentoring and training peers
  • Cross-functional collaboration
  • Strong organizational skills
  • Effective communication skills
  • Experience in drug substance manufacturing
  • Experience in syringe and cartridge manufacturing

Key Requirements

  • Bachelor's Degree in Life Science or related discipline
  • Minimum 5 years quality assurance experience in pharma/biotech manufacturing
  • Experience reviewing and approving batch records
  • Knowledge of FDA/EMA regulations
  • Experience conducting and approving investigations

Work Rights

Not specified

Tailored Resume

Cover Letter