Career Category Quality Job Description At Amgen, our shared mission—to serve patients—drives all that we do. As a Senior Associate Plant QA at Amgen Breda, you will support the manufacturing process by providing essential Quality Assurance guidance during packaging and labeling activities. This role operates on a rotating shift schedule and includes a 25.1% shift allowance as part of the compensation package.

The Role

In this role, you will ensure products are manufactured, documented, and released in compliance with GMP requirements while collaborating closely with Production and other cross-functional teams. Your responsibilities will include performing Quality Pack Checks, reviewing batch documentation, supporting investigations, and contributing to continuous improvement initiatives.

Responsibilities

• Provide daily QA guidance and support to Production teams, ensuring compliance with SOPs, Work Instructions, and GMP requirements.
• Act as the primary contact for quality-related inquiries during packaging and labeling operations.
• Review and approve batch production record entries before manufacturing begins.
• Conduct Quality Pack Checks and finished product inspections during production runs.
• Compile, review, and verify batch records for products assembled, packaged, and labeled at Amgen Breda and contract manufacturing sites for QP disposition.
• Review and approve deviation records, ensuring timely and accurate investigations.
• Collaborate with cross-functional teams to address quality-related issues and implement CAPAs.
• Support QA-related projects, system improvements, and continuous improvement initiatives.

Requirements

• Bachelor's degree in Life Sciences or a related field, or equivalent education and experience.
• Approximately three years of Quality Assurance or pharmaceutical manufacturing experience in a GMP-regulated environment.
• Experience with batch record review, deviation management, and quality investigations.
• Strong knowledge of GMP, GDP, and/or GCP, with the ability to apply quality principles in daily operations.
• Understanding of pharmaceutical manufacturing processes and quality systems.
• Excellent attention to detail, analytical thinking, and problem-solving abilities.
• Strong communication and collaboration skills to build effective relationships across functions.
• Fluency in English, both written and spoken.

What We Offer

• Opportunities for professional and personal growth within our global organization.
• A diverse and inclusive workplace that empowers innovation and contribution.
• Competitive Total Rewards package, including an attractive salary, 25.1% shift allowance, annual bonus, fixed 13th month, holiday allowance, and collective health insurance.
• Focus on well-being with an on-site gym, vitality program, and healthy meal options.

Amgen is committed to discovering, developing, manufacturing, and delivering innovative human therapeutics for patients suffering from serious illnesses. Join us in our mission to improve health outcomes and transform lives. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.