Risk Assessment Specialist

Job Overview

Legend Biotech USA, Inc. seeks a Risk Assessment Specialist in Raritan, NJ.

• Conduct Quality Risk Assessments (QRM per ICH Q9) for manufacturing processes, QC systems, and equipment, applying FMEA, HACCP, HAZOP, and Pareto analysis.
• Develop, execute, and review validation master plans, cleaning validation, and method transfer protocols.
• Prepare and review technical documentation.
• Collaborate with QA, QC, Manufacturing, Engineering, and R&D teams.
• Analyze data from risk assessments and validation studies, identify gaps, and recommend actions.
• Track and report progress on risk assessment activities.
• Provide subject matter expertise on ICH Q9 Quality Risk Management, FDA, and cGMP compliance.
• Perform related duties as assigned to maintain compliance with FDA, ICH, and GMP standards.

• BS degree in Biology, Biotechnology, Chemistry, Engineering, or related technical field (foreign equivalent acceptable).
• Minimum 12 months experience as a Risk Assessment Specialist, Project Manager, Data Analyst, or related occupation.
• Proficiency in risk assessment tools such as FMEA, FTA, Pareto analysis, HAZOP, and/or HACCP.

Travel: less than 5% as needed, monthly.

Salary: $81,037/yr.

Apply:
Mail CV to Legend Biotech USA, Inc., Attn:

E. McShane, 2101 Cottontail Ln., Somerset, NJ 08873.