Risk Assessment Specialist

Legend Biotech USA, Inc.

Raritan, NJ, United States
Base: $81,037pyr; bonus/equity: performance-based ...
On-site
Ich q9 quality risk management expertise
Fmea, haccp, hazop, and pareto analysis skills
Validation master plan development experience
Legend Biotech is a global biotechnology company dedicated to treating life-threatening diseases through advanced cell therapies

Job Summary

  • Legend Biotech is a global biotechnology company dedicated to treating life-threatening diseases through advanced cell therapies.
  • The role involves conducting Quality Risk Assessments (QRM) per ICH Q9 for manufacturing processes, QC systems, and equipment.
  • Employees receive comprehensive benefits including medical insurance, a 401(k) match vesting on day one, and eight weeks of paid parental leave.

Matching Summary

Legend Biotech is a global biotechnology company dedicated to treating life-threatening diseases through advanced cell therapies.

Salary

Base: $81,037/yr; Bonus/Equity: Performance-based bonus and/or equity available; Benefits: Medical, dental, vision, 401(k), and paid time off

Skills & Requirements

Must-have

  • ICH Q9 Quality Risk Management expertise
  • FMEA, HACCP, HAZOP, and Pareto analysis skills
  • Validation master plan development experience

Nice-to-have

  • Cross-functional collaboration with R&D teams
  • Data analysis and gap identification capabilities
  • Subject matter expertise in FDA compliance

Key Requirements

  • BS degree in Biology, Biotechnology, Chemistry, or Engineering
  • 12 months of experience as Risk Assessment Specialist or related role
  • Proficiency in risk assessment tools like FMEA and HAZOP

Work Rights

Not specified

Tailored Resume

Cover Letter