Senior QA Specialist - GMP, CAPA & Deviation Expert

Amgen; West Greenwich (RI); Presencial; USD 104.000 - 141.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Retirement plan

Medical, dental and vision coverage

Stock-based incentives

Flexible work models

Descripción de la vacante

Amgen seeks a Quality Assurance Specialist to safeguard GMP manufacturing, testing, storage, and distribution across the network. You will act as a SME for deviation, CAPA, change control and risk management, driving improvements and ensuring robust quality systems.

Qualified candidates bring extensive QA and manufacturing experience, strong documentation and cross-functional collaboration skills, and a proven ability to translate quality requirements into practical actions in a fast-paced

Formación

• High school diploma or GED with 10 years in Quality, Manufacturing, Process Development or Process Engineering.
• Associate’s degree with 8 years in Quality, Manufacturing, Process Development or Process Engineering.
• Bachelor’s degree with 4 years in Quality, Manufacturing, Process Development or Process Engineering.
• Master’s degree with 2 years in Quality, Manufacturing, Process Development or Process Engineering.
• Doctorate degree in a relevant field.

Responsabilidades

• Provide quality oversight to ensure GMP-conformant manufacturing, testing, storage, and distribution.
• Serve as SME for Deviation, CAPA, Change Control and risk management processes.
• Develop and maintain understanding of applicable requirements and best practices.
• Offer risk-based quality advice for investigations, corrective actions, and change control.
• Review and approve GMP documents, records, and procedures; ensure inspection readiness.
• Collaborate with project teams to integrate quality into planning and execution.
• Independently assess and prioritize quality risks across functions.
• Drive continuous improvement initiatives across site and network.
• Maintain relationships within Amgen to benchmark and share best practices.

Conocimientos

Quality

Manufacturing

Process Development

Process Engineering

CAPA

Deviation

Change Control

Risk management

Documentation

Communication

Educación

High school diploma or GED

Associate’s degree

Bachelor’s degree

Master’s degree

Doctorate degree

Descripción del empleo

Amgen seeks a Quality Assurance Specialist to safeguard GMP manufacturing, testing, storage, and distribution across the network. You will act as a SME for deviation, CAPA, change control and risk management, driving improvements and ensuring robust quality systems.

Qualified candidates bring extensive QA and manufacturing experience, strong documentation and cross-functional collaboration skills, and a proven ability to translate quality requirements into practical actions in a fast-paced