Risk Assessment Specialist
The Risk Assessment Specialist at Legend Biotech USA, Inc. plays a pivotal role in ensuring the safety and compliance of manufacturing processes, quality control systems, and equipment. This position is integral to the company's mission of developing advanced cell therapies to treat life-threatening diseases.
Key responsibilities include conducting Quality Risk Assessments (QRM) in line with ICH Q9 guidelines, utilizing methodologies such as FMEA, HACCP, HAZOP, and Pareto analysis. The specialist will develop, execute, and review validation master plans, cleaning validation, and method transfer protocols. Collaboration with cross-functional teams—including Quality Assurance, Quality Control, Manufacturing, Engineering, and Research & Development—is essential to analyze data from risk assessments and validation studies, identify gaps, and recommend corrective actions.
Candidates must possess a Bachelor's degree in Biology, Biotechnology, Chemistry, Engineering, or a related technical field. A minimum of one year of experience in roles such as Risk Assessment Specialist, Project Manager, or Data Analyst is required. Proficiency in risk assessment tools like FMEA, FTA, Pareto analysis, HAZOP, and HACCP is essential. The role may require less than 5% travel on a monthly basis.
The position offers a base salary of $81,037 per year. Additional compensation includes performance-based bonuses and/or equity for eligible roles. Benefits encompass medical, dental, and vision insurance, a 401(k) retirement plan with immediate vesting, paid parental leave, and a comprehensive paid time off policy. Additional voluntary benefits are also available.
Legend Biotech fosters a collaborative and innovative work environment, dedicated to advancing cell therapies for patients worldwide. Employees are encouraged to contribute to the company's mission and have opportunities for professional growth within a dynamic and supportive setting.