QA Specialist, Deviations

QA Specialist, Deviations

Role Overview

The QA Specialist, Deviations provides Quality Assurance oversight and subject matter expertise for deviations, investigations, CAPAs, and change controls. Working closely with Manufacturing, Engineering, Validation, Quality Control, and Supply Chain, the role ensures quality investigations are managed effectively and in compliance with GMP requirements, regulatory expectations, and Amgen standards.

Key Responsibilities

• Provide QA oversight of deviations, investigations, CAPAs, and change controls, ensuring timely and compliant execution.
• Review and approve quality records, ensuring appropriate scope, root cause analysis, risk assessment, and corrective actions.
• Represent QA at Deviation Review Boards, Change Control Boards, and other cross-functional forums.
• Support complex investigations and provide quality guidance on compliance and operational issues.
• Monitor quality system trends and support continuous improvement initiatives.
• Contribute to Annual Product Reviews and quality metrics reporting, as required.
• Support internal audits, regulatory inspections, and inspection readiness activities.
• Perform all activities in compliance with Amgen safety standards and SOPs.
• Responsibilities may expand to include additional areas aligned with business needs.

Preferred Qualifications and Experience

• Bachelor's degree in Science, Engineering, Pharmacy, Biotechnology, or a related discipline.
• Minimum 5 years' experience in the pharmaceutical or biotechnology industry.
• Experience providing QA oversight of deviations, investigations, CAPAs, and change controls in a GMP environment.
• Strong understanding of GMP requirements, quality systems, and risk management principles.
• Strong analytical, problem-solving, communication, and stakeholder management skills.
• Ability to work independently and effectively in a cross-functional environment.
• Excellent organisational, communication, coordination, and meeting facilitation skills.

• Proven track record of supporting continuous improvement initiatives within a regulated environment.