Specialist QA - Indirect Plant Technical Quality Assurance

Role Overview

The Indirect Plant Technical Quality Assurance (QA) Specialist is a key role within the QA function, responsible for providing expert quality oversight and guidance across critical processes. This position requires subject matter expertise in assigned areas and the ability to operate across functional boundaries to ensure compliance with GMP and internal standards.

Key Responsibilities

• Act as QA representative at Change Control and Deviation Review Boards, providing quality direction and input.
• Assume QA oversight of change control and deviation/CAPA records, ensuring clear scope and robust, timely implementation activities.
• Review and approve validation documentation and SOPs to support site validation activities as required.
• Provide input into Annual Product Reviews (APRs).
• Support a safe working environment by complying with all environmental health and safety practices, rules, and regulations.
• 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

• University degree in Science or Engineering (preferred).
• Minimum 5 years’ experience in the pharmaceutical or biotechnology industry, with demonstrated expertise in providing quality oversight for key functional areas (e.g., Manufacturing, Validation, Quality Control).
• Demonstrated ability to act as a Subject Matter Expert in QA processes and systems.
• Strong understanding of validation principles.
• At least 18 months’ experience as QA contact on major deviations.
• Proven experience in change control, CAPA management, and validation practices.
• Ability to work independently and remotely with minimal supervision.
• Excellent organisational, communication, coordination, and meeting facilitation skills.
• Strong critical thinking and problem-solving abilities.
• Collaborative team player, embracing a culture of shared decision-making.

• Familiarity with regulatory requirements and industry standards for GMP compliance.
• Experience in reviewing and approving validation protocols and reports.
• Proven track record of supporting continuous improvement initiatives within a regulated environment.