Career Category

Quality

Job Description

Specialist – QA Technical Support NPI

Live

What you will do

Let’s do this. Let’s change the world.

Amgen discovers, develops, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realise the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.

The Quality Assurance Technical Support Specialist NPI (New Product Introduction) is a senior position within the QA function which will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility. This is a unique opportunity to play a key role in a high-impact function, providing Quality Oversight for validation and technology transfer activities supporting the introduction of new lines/equipment, new product introduction and product lifecycle changes. This role requires a strong focus on QA leadership in the qualification of facilities, equipment, and process validation ensuring all qualification and validation activities meet Amgen and regulatory standards.

Key Responsibilities

• Provide overall quality direction and oversight for key functional areas (i.e. PD, Validation and Operations), ensuring that programs, policies and procedures are robust and in keeping with regulatory and Amgen expectations.
• Serve as the QA Lead for technology transfer and NPI activities for Aseptic product, providing quality oversight throughout process validation and product lifecycle introduction.
• Serve as the QA point of contact and decision-maker during validation execution, ensuring adherence to regulatory and internal standards.
• Lead QA review and approval of technology transfer and validation documentation including process descriptions, Validation Plans, protocols, validation reports, and risk assessments.
• Lead QA review and approval of SAP BOMs, MBRs and recipes.
• Partner cross-functionally with PD, Engineering, and Operations teams to ensure all NPI activities are compliant with regulatory and site quality requirements.
• Provide quality direction and input for Change Controls, CAPAs, and Deviation Investigations.
• Support inspection readiness and regulatory audits, representing QA for validation and NPI areas.
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
• Perform all activities in compliance with Amgen safety standards and SOPs

Win

What we expect of you

The successful candidate for this role will bring the following education, skills and experience

• University degree in a Science-related discipline.
• Minimum of 7 years’ relevant experience in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing)
• In-depth knowledge of applicable regulatory requirements and experience with regulatory inspections.
• Experience working in aseptic operations, relating to vial and syringe filling.
• Understanding of principles of Validation and New Product Introduction
• Proven experience in Quality Systems (change control, non-conformance, corrective and preventative actions).
• Strong organizational skills with the ability to manage tasks through to completion.
• Ability to work independently and remotely with minimum direct supervision.
• Strong critical thinking and problem-solving abilities
• Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.
• Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

Thrive

What you can expect of us

In addition to a competitive salary structure, Amgen offers a generous Total Rewards Plan for staff and eligible dependents. Comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, life and disability insurance. Discretionary annual bonus program. Exceptional learning, development and career advancement opportunities, empowering employees to grow and build long-term careers. At Amgen, we are committed to nurturing talent and providing meaningful pathways for professional development.

Amgen is an equal opportunities employer

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