Investigator II: Quality Investigations & CAPA Leader

Legend Biotech US; Raritan (NJ); Sur place; USD 73 000 - 103 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid time off

Résumé du poste

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

Qualifications

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

Responsabilités

• 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.

Connaissances

cGMP experience

investigations

risk assessment

Formation

BS/BA in engineering or science

Outils

eQMS

Description du poste

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