QC Investigation Specialist

Job Description

Legend Biotech is seeking a QC Investigation Specialist to lead deviations and corrective actions within QC testing laboratories, supporting the manufacturing of cell therapy products. This role is based in a controlled GMP environment in Ghent, Belgium.Responsibilities include:

• Managing QC-related deviations.
• Executing qualitative investigations.
• Performing root cause analysis.
• Implementing CAPAs.
• Reviewing and completing nonconformance/deviation investigations.
• Providing quality insight to complete laboratory investigation reports in Trackwise.
• Recommending process improvements.
• Monitoring metrics on non-conformance investigations and CAPA.

Requirements:

• A minimum of a Bachelor’s Degree in Science, Engineering, or equivalent.
• A minimum of 4 years of relevant work experience.
• Experience in a Quality Control setting is preferred.
• Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required.
• Knowledge of cGMP regulations and FDA/EU guidance.
• Knowledge of Good Tissue Practices.
• Excellent written and oral communication skills.

Legend Biotech offers:

• Opportunity to work in cell therapy manufacturing.
• A role focused on continuous improvement.
• A position within a diverse and inclusive workforce.