Investigator II: Quality Investigations & CAPA Leader

Legend Biotech US; Raritan (NJ); Presencial; USD 73.000 - 103.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid time off

Descripción de la vacante

Legend Biotech US in Raritan, NJ is seeking an Investigator I/II to independently lead investigations across manufacturing, facilities, equipment, and validation systems. You will assess product quality, patient safety, and regulatory significance with a science- and risk-based approach, and develop robust CAPA strategies.

You will collaborate with SMEs and Quality leads to ensure inspections readiness, support internal audits, and drive continuous improvement in investigation processes and

Formación

• Proven ability to independently manage multiple investigations.
• Experience performing risk assessments and root-cause analyses.
• Strong technical writing and scientific reporting skills.

Responsabilidades

• Lead end-to-end investigations related to manufacturing, facilities, equipment and validation systems.
• Review data from manufacturing records, environmental monitoring, and maintenance logs for root causes.
• Develop CAPAs and ensure timely closure with effectiveness verification.
• Present findings to cross-functional teams and auditors as needed.

Conocimientos

cGMP experience

investigations

risk assessment

Educación

BS/BA in engineering or science

Herramientas

eQMS

Descripción del empleo

Legend Biotech US in Raritan, NJ is seeking an Investigator I/II to independently lead investigations across manufacturing, facilities, equipment, and validation systems. You will assess product quality, patient safety, and regulatory significance with a science- and risk-based approach, and develop robust CAPA strategies.

You will collaborate with SMEs and Quality leads to ensure inspections readiness, support internal audits, and drive continuous improvement in investigation processes and