QA Lot Disposition Manager — GMP & Compliance Leader

AGC Biologics; Bothell (WA); Presencial; USD 94.000 - 129.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus opportunities

Paid time off

Medical coverage

Dental coverage

Vision coverage

Parental leave

Education assistance

Employee referral and recognition

Wellbeing benefits

Descripción de la vacante

AGC Biologics in Bothell, WA is seeking a Manager, Lot Disposition to lead review, approval, and disposition of manufactured drug substance batches and raw materials, ensuring timely, compliant release. You will mentor a QA team, drive CAPAs and deviations closure, and partner with Manufacturing, MSAT, and Quality Control to sustain inspection readiness and continuous improvement.

The role emphasizes data-driven decision-making, metrics reporting, and managing resource allocation to meet

Formación

• Bachelors with 8+ years of industry experience or Master’s with 6+ years.
• Experience supporting batch review, lot disposition, and quality systems in GMP environment.
• Leadership experience managing teams and cross-functional activities.

Responsabilidades

• Lead QA support for review and approval of batch records and manufacturing documentation.
• Perform lot disposition activities for manufactured drug substances and raw materials.
• Review and approve deviations, change controls, and CAPAs; validate documents.

Conocimientos

Leadership

Decision making

Problem solving

Cross-functional collaboration

GMP quality systems

Educación

Bachelor's degree

Master's degree

Descripción del empleo

AGC Biologics in Bothell, WA is seeking a Manager, Lot Disposition to lead review, approval, and disposition of manufactured drug substance batches and raw materials, ensuring timely, compliant release. You will mentor a QA team, drive CAPAs and deviations closure, and partner with Manufacturing, MSAT, and Quality Control to sustain inspection readiness and continuous improvement.

The role emphasizes data-driven decision-making, metrics reporting, and managing resource allocation to meet