Lead Manufacturing Investigations Specialist

Amgen; West Greenwich (RI); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Group medical insurance

Life and disability insurance

Flexible Spending Accounts

Annual bonus program

Stock-based incentives

Award-winning time-off plans

Flexible work models

Job summary

Amgen seeks a Sr. Specialist Manufacturing in Rhode Island to lead major deviation investigations and provide technical leadership across cross-functional teams. You will drive science-based decision making and operate as a subject matter expert to improve investigation processes.

The role requires strong CAPA strategy, risk-based thinking, and collaboration with Quality, Regulatory, and Manufacturing groups to ensure compliance and continuous improvement in a GMP environment.

Qualifications

• Demonstrated expertise in deviation management systems and CAPA within GMP-regulated environments.
• Experience presenting and defending investigation decisions during audits and inspections.
• Ability to lead cross-functional projects and manage multiple priorities with timely delivery.
• Strong written, verbal, and presentation skills to influence stakeholders.

Responsibilities

• Serve as technical lead and Major Deviation Owner for complex investigations from initiation to closure.
• Lead in-field investigation activities and coach teams to ensure high-quality outcomes.
• Act as SME, mentoring and sharing knowledge to build technical capability.
• Drive cross-site standardization and enterprise best practices for investigations.
• Represent the organization during internal audits and regulatory inspections with defense of strategy and compliance decisions.
• Identify and lead continuous improvement initiatives including AI-enabled investigation tools.
• Influence quality strategy to strengthen product quality and inspection readiness.
• Lead cross-functional problem-solving with Manufacturing, Engineering, Process Development, Quality Control, Supply Chain and Regulatory Affairs.

Skills

Deviation management

Root cause investigations

CAPA strategy

Quality systems

Education

Bachelor's degree in a relevant field

Master's degree

Doctorate degree

Job description

Amgen seeks a Sr. Specialist Manufacturing in Rhode Island to lead major deviation investigations and provide technical leadership across cross-functional teams. You will drive science-based decision making and operate as a subject matter expert to improve investigation processes.

The role requires strong CAPA strategy, risk-based thinking, and collaboration with Quality, Regulatory, and Manufacturing groups to ensure compliance and continuous improvement in a GMP environment.