Sr Associate Manufacturing - Compliance

If you feel like your part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us as:

Sr Associate Manufacturing (Compliance) – Operation Excellence team

At Amgen Breda medicines are labelled, assembled, stored and eventually shipped to various countries worldwide. Every day more than 1000 people with 42 different nationalities are working on supply chain processes, manufacturing, marketing and sales of our medicines and clinical research into new medicines.

Live

What you do

As a Senior Associate Manufacturing on the Operational Excellence Team Compliance at Amgen, you will play a crucial role in supporting and leading deviation investigations and implement corrective actions to ensure compliance with regulatory requirements and internal standards. You will conduct risk assessments, manage and maintain documentation related to manufacturing processes, and assist in complaint investigations.

In this role, you will drive continuous improvement initiatives to improve manufacturing processes and compliance, ensuring that safety and quality standards are executed flawlessly to deliver high-quality products. You will also provide training and support for manufacturing staff to ensure compliance with processes and procedures.

This position is ideal for someone with a keen eye for detail, strong problem-solving skills, and a passion for maintaining high standards in manufacturing operations.

Furthermore, in a highly dynamic environment like manufacturing, you must have a “walk the extra mile” attitude and stress resistant. 

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

In this vital role you will:

• Support and lead Major deviation investigations to ensure compliance with regulatory requirements and internal standards.
• Conduct risk assessments to identify potential issues and implement corrective actions.
• Manage and maintain documentation related to manufacturing processes and compliance.
• Assist in investigating material-related issues to ensure smooth manufacturing operations.
• Support investigations by providing assessments related to manufacturing process controls
• Become actively involved when required to resolve complex operational issues.
• Drive continuous improvement initiatives to enhance manufacturing processes and compliance.
• Ensure that safety and quality standards are executed flawlessly to deliver high-quality products.
• Provide training and support to manufacturing staff to ensure compliance with processes and procedures

Win

What we expect from you

We are all different, yet we all use our outstanding contributions to serve patients. The problem-solving professional we seek is a strong leader with these qualifications:

• Bachelor degree (relevant education) or the equivalent combination of education and experience.
• Minimum 3 years of related experience in an industrial environment.
• Experience in a pharmaceutical / GMP environment.
• Knowledge and understanding of Good Manufacturing Practices
• Experience in technical writing. 
• Proficient in English, both in oral and written communication.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we work to care for our teammates’ professional and personal growth and well-being. Therefore, Amgen is regularly recognized as a Best Place To Work ©.

• Vast opportunities to learn and move up and across our global organization.
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
• Generous Total Rewards Plan comprising competitive salary, bonus structure, fixed 13th month, holiday allowance and collective health insurance.
• Focus on vitality with an on-site gym, vitality program