QA Technical Services Specialist – Quality & Compliance

Amgen SA; West Greenwich (RI); On-site; USD 90,000 - 120,000; Full time

Job summary

Amgen is seeking a Quality Assurance Specialist for the ARI site in the United States. The role provides quality oversight across key processes, including deviations, CAPA, and change controls, with a focus on maintaining compliance within the quality management system.

You will collaborate with cross-functional teams and ensure readiness for inspections. The role requires strong risk-based decision making, broad QA competencies, and the ability to work autonomously in a fast-paced environment.

Qualifications

• 10+ years of Quality, Manufacturing, or Process Engineering experience.
• Associate’s degree with 8+ years experience in Quality/Manufacturing/Process Engineering.
• Bachelor’s degree with 4+ years experience in Quality/Manufacturing/Process Development/Process Engineering.
• Master’s degree with 2+ years experience in Quality/Manufacturing/Process Development/Process Engineering.
• Doctorate degree in relevant field.

Responsibilities

• Provide quality oversight to ensure products are manufactured, tested, stored, and distributed per GMP.
• Serve as SME for Deviation, CAPA, Change Control and risk management processes on site.
• Develop and maintain understanding of applicable requirements and best practices.
• Provide risk-based quality advice for investigations, corrective actions, and change control.
• Manage quality processes and ensure changes are evaluated for impact to quality.

Skills

Quality Assurance

GMP familiarity

CAPA & Change Control

Education

Bachelor’s degree

Master’s degree

Doctorate degree

Tools

Deviation handling

Risk assessment

Job description

Amgen is seeking a Quality Assurance Specialist for the ARI site in the United States. The role provides quality oversight across key processes, including deviations, CAPA, and change controls, with a focus on maintaining compliance within the quality management system.

You will collaborate with cross-functional teams and ensure readiness for inspections. The role requires strong risk-based decision making, broad QA competencies, and the ability to work autonomously in a fast-paced environment.