Sr. Associate Ii, Quality Assurance

Biogen

Research Triangle Park, NC, United States
Base: $93,000.00-$121,000.00; bonus/equity: cash b...
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Quality management systems
Regulatory compliance
Cgmp
** Biogen is seeking a Sr. Associate II in Quality Assurance for its Research Triangle Park facility. This full-time, on-site role requires extensive experience in quality assurance within a GMP environment, with a focus on regulatory compliance and continuous improvement. **

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 has advanced understanding of the Quality Management Systems and applies that knowledge by coaching peers and ensuring continuous improvement cross-functionally.
  • 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

Match Score: 75

** Biogen is seeking a Sr. Associate II in Quality Assurance for its Research Triangle Park facility. This full-time, on-site role requires extensive experience in quality assurance within a GMP environment, with a focus on regulatory compliance and continuous improvement. **

Salary

Base: $93,000.00-$121,000.00; Bonus/Equity: Cash bonus and equity incentive opportunities; Benefits: Medical, Dental, Vision, & Life insurances, Fitness & Wellness programs, Disability insurance, Paid time off, Holidays, Paid Parental Leave, 401(k) program, Employee stock purchase plan, Tuition reimbursement

Skills & Requirements

Must-have

  • Quality Management Systems
  • regulatory compliance
  • cGMP
  • data integrity governance
  • ALCOA+ principles
  • batch record review
  • product disposition
  • GxP quality systems

Nice-to-have

  • continuous improvement
  • risk assessments
  • cross-functional collaboration
  • mentorship and training

Key Requirements

  • Bachelor’s Degree or Associate's Degree plus 7+ years of experience
  • Minimum 5 years of relevant quality assurance experience
  • Experience reviewing and approving batch records, master records, SOPs and technical documents
  • Experience conducting and explaining investigations
  • Experience working on the floor within manufacturing environment
  • Advanced understanding of global quality systems applications, principles, concepts, practices and standards and GxP regulations

Work Rights

Not specified

Tailored Resume

Cover Letter