Risk Assessment Specialist
Listed on 2026-06-04
-
Engineering
QA Specialist / Manager -
Quality Assurance - QA/QC
Quality Control / Manager, QA Specialist / Manager
Responsibilities
- Conduct Quality Risk Assessments (QRM per ICH Q9) for manufacturing processes, QC systems, and equipment.
- Apply risk assessment methodologies such as 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).
- 12 months of experience as a Risk Assessment Specialist, Project Manager, Data Analyst, or related occupation.
- Proficiency with risk assessment tools such as FMEA, FTA, Pareto analysis, HAZOP, and/or HACCP.
- Availability to travel less than 5% as needed, monthly.
- Salary: $81,037 per year.
These benefits are offered exclusively to permanent full‑time employees. Contractors are not eligible for benefits through Legend Biotech.
EEO StatementIt is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company.
#J-18808-Ljbffr(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).