Biologics Deviation Investigator and Process Lead

Amgen; Holly Springs (NC); Presencial; USD 108.000 - 146.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Retirement plan

Bonus program

Stock-based incentives

Descripción de la vacante

Amgen is seeking a highly experienced investigator to lead major deviation investigations at the North Carolina biologics manufacturing site. You will interface with GMP manufacturing, process development, facilities, automation, EHSS, and Quality to ensure compliant investigations and effective CAPAs.

The role requires strong project management, cross-functional collaboration, and clear technical writing. Flexible work models and competitive benefits are included.

Formación

• Experience with compliance, problem-solving, and root cause analysis tools (5-whys, fishbone, Kepner Tregoe).
• Ability to manage major deviation investigations and develop CAPAs.
• Strong documentation and technical writing skills.
• Experience presenting to inspectors during regulatory inspections and internal audits.

Responsabilidades

• Manage major deviation investigations, assemble teams, lead root cause analyses, and document findings.
• Drive improvements to the investigation process and present findings to stakeholders.
• Coordinate cross-functional teams through complex investigations and meet milestones.

Conocimientos

Root cause analysis

Problem solving

Cross-functional collaboration

Regulatory communications

Educación

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

Herramientas

Veeva QMS

Descripción del empleo

Amgen is seeking a highly experienced investigator to lead major deviation investigations at the North Carolina biologics manufacturing site. You will interface with GMP manufacturing, process development, facilities, automation, EHSS, and Quality to ensure compliant investigations and effective CAPAs.

The role requires strong project management, cross-functional collaboration, and clear technical writing. Flexible work models and competitive benefits are included.