QA Lot Disposition Manager — GMP & Cross-Functional Lead

AGC Biologics, Inc.; Bothell (WA); Presencial; USD 94 000 - 129 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Annual bonus opportunities

Medical, dental & vision coverage

Parental leave

Education assistance

Employee referral and recognition

Resumo da oferta

AGC Biologics, Inc. in Bothell, WA is seeking a Manager of Lot Disposition to lead batch review, disposition, and release activities.

This role partners with Manufacturing, QC, MSAT, and other functions to close deviations, CAPAs, and change controls while driving compliance and continuous improvement. You will mentor the Lot Disposition team, ensure timely product release, and support regulatory inspection readiness.

Qualificações

• Requires Bachelor’s degree with 8+ years of industry experience or Master’s with 6+ years.
• Experience supporting batch review, lot disposition, and quality systems within a GMP environment.
• Prior leadership experience managing teams and cross-functional activities.

Responsabilidades

• Lead QA support for the review and approval of batch records and related manufacturing documentation.
• Review and approve executed batch records and product testing records.
• Perform lot disposition activities for manufactured drug substance and raw materials.
• Review and approve moderate-complexity deviations, change controls, and associated CAPAs.
• Review and approve validation documents.
• Partner with cross-functional teams to investigate and resolve quality and compliance issues.
• Drive continuous improvement of quality systems, compliance, and efficiency.
• Represent QA on cross-functional project teams and support moderately complex projects.
• Lead management of lot disposition metrics and performance reporting.
• Support regulatory inspection readiness activities.
• Manage daily operations and priorities for the Lot Disposition team.
• Allocate resources and ensure work aligns with objectives.
• Coach and develop team members to build capability and performance.

Conhecimentos

Leadership

Decision-making

Cross-functional collaboration

GMP knowledge

Prioritization

Formação académica

Bachelor's degree with 8+ years experience

Master's degree with 6+ years experience

Descrição da oferta de emprego

AGC Biologics, Inc. in Bothell, WA is seeking a Manager of Lot Disposition to lead batch review, disposition, and release activities.

This role partners with Manufacturing, QC, MSAT, and other functions to close deviations, CAPAs, and change controls while driving compliance and continuous improvement. You will mentor the Lot Disposition team, ensure timely product release, and support regulatory inspection readiness.