Amgen Senior Associate Plant Quality Assurance in Breda, Netherlands

Amgen is a values-based organization with a powerful sense of shared purpose toward our mission: to serve patients. We provide the capabilities, resources, and rewards of a global enterprise, while maintaining the entrepreneurialism and pioneering spirit that marked our early days as a biotechnology innovator. We encourage our team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities such as this:

Senior Associate Plant Quality Assurance

Amgen Europe B.V.

Amgen Europe B.V. is based in the South of the Netherlands, in the beautiful city of Breda and is part of Amgen's global manufacturing network, including eight manufacturing plants around the globe.

The main Operations conducted at Amgen Breda are:

Production: Labeling, Assembly and Secondary Packaging of Amgen product

Product release tot he market

Distribution to 75+ countries worldwide

These activities are shared amongst several organizations such as Production, Supply Chain, Quality Assurance, Information Services, Finance, Marketing & Sales and HR. With approximately 600 employees, the entire site of Amgen Breda works towards one common goal: to serve 'every patient, every time'.

As Sr. Associate Plant QA you will be part of a big group made of 9 other experienced Sr. Associates and 4 Specialists - Qualified Persons. You will keep quality oversight of the activities performed in Amgen Breda Labeling and Packaging Hall. You will be working in shifts, partnering with Production and Maintenance and Engineering staff members.

You will use your broad Good Manufacturing Practice, process and product knowledge to provide Quality decisions and drive quality improvements. Your main tasks consists of performing product inspections, reviewing batch information and act as Quality Assurance representative in evaluation, approval and improvement on quality related events.

Job Responsibilities:

Act as a first point of contact to Production and Maintenance and Engineering in case of quality related production problems during packaging and labeling operations and take quality related decisions, where needed in corporation with the Qualified Person.

Approve batch related exceptions and class I Non Conformances

Perform finished product checks during production runs

Review batch information in preparation for product release to the market

Approve equipment maintenance plans

Review and approve test protocols before use in production

Perform routine GMP compliance checks in production

Assist in development and execution of GMP training activities for QA and production staff

Assist in various investigations as needed

Assist in ABR projects and improvement efforts as needed

Maintain departmental performance boards

A Fortune 150 company operating in nearly 100 countries around the world, we invest in highly skilled, dedicated and collaborative individuals who are ready to contribute to our mission in meaningful ways and make a difference in the lives of our patients.

That's why, as a member of the Amgen team, we provide you with valuable opportunities to broaden your experience and maximize your potential. We ensure our staff are equipped to excel today and tomorrow by leveraging state-of-the-art technologies and modern working environments, encouraging open dialogue and professional debate, and collaborating with world-class talent and institutions around the globe. We believe in rewarding those who do rewarding work and are committed to providing careers that can help turn the tide of serious, life-interrupting illnesses.

Please note:

An online assessment is part of the recruitment process.

For this position we only consider candidates who live in the Netherlands or on a commuting distance from our Breda office, no relocation fee is offered for the position.