Description
Legend Biotech USA, Inc. seeks Risk Assessment Specialist in Raritan, NJ to: conduct Quality Risk Assessments (QRM per ICH Q9) for manufacturing processes, QC systems, and equipment, applying methodologies such as FMEA, HACCP, HAZOP, and Pareto analysis; develop, execute, and review validation master plans, cleaning validation, & method transfer protocols; prepare & review technical documentation; collaborate with QA, QC, Manufacturing, Engineering, and R&D teams; analyze data from risk assessments and validation studies, identify gaps, & recommend actions; track & 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.
Req.BS degree in Biology, Biotechnology, Chemistry, Eng’g, or related technical field (foreign equiv. acceptable) and 12 mos. exp. as Risk Assessment Specialist, Project Mgr., Data Analyst, or related occ. Req skills: Risk assessment tools such as FMEA,FTA, Pareto analysis, HAZOP and/or HACCP. Travel: less than 5% as needed, monthly. Salary: $81,037/yr. Mail CV to Legend Biotech USA, Inc., Attn: E. McShane, 2101 Cottontail Ln., Somerset, NJ 08873.
