Risk Assessment Specialist
About The Position
Legend Biotech USA, Inc. seeks a 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. The role involves developing, executing, and reviewing validation master plans, cleaning validation, & method transfer protocols. The specialist will prepare & review technical documentation, collaborate with QA, QC, Manufacturing, Engineering, and R&D teams, and analyze data from risk assessments and validation studies to identify gaps and recommend actions. Responsibilities also include tracking & reporting progress on risk assessment activities and providing subject matter expertise on ICH Q9 Quality Risk Management, FDA, and cGMP compliance. Related duties will be performed as assigned to maintain compliance with FDA, ICH, and GMP standards.
Requirements
- BS degree in Biology, Biotechnology, Chemistry, Eng’g, or related technical field (foreign equiv. acceptable).
- 12 months of experience as Risk Assessment Specialist, Project Mgr., Data Analyst, or related occupation.
- Risk assessment tools such as FMEA, FTA, Pareto analysis, HAZOP and/or HACCP.
Responsibilities
- 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.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) retirement plan with a company match that vests fully on day one
- Eight (8) weeks of paid parental leave after just three (3) months of employment
- Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays
- Flexible spending accounts
- Health savings accounts
- Life and AD&D insurance
- Short- and long-term disability coverage
- Legal assistance
- Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
- Voluntary commuter benefits
- Family planning and care resources
- Well-being initiatives
- Peer-to-peer recognition programs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
