If you feel like you’re 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 Plant QA – Trainee QP

　　At Amgen Breda, medicines are labeled, assembled, stored, and eventually shipped to various countries worldwide. Every day more than 1000 people from 38 different nationalities are working on supply chain processes, manufacturing, marketing, and sales of our medicines and clinical research into new medicines.

　　LIVE

　　What you will do

　　As the Sr. Associate Plant QA – Trainee QP , you will play a crucial role in ensuring the highest standards of quality and compliance within the production area. Your primary responsibilities will include providing expert QA guidance and support throughout the production process.

　　A key aspect of your role will involve meticulous batch record review for batches assembled, packaged, and labeled both at ABR and at our contract manufacturers. This critical evaluation ensures that each product meets the stringent quality standards set by regulatory authorities and internal protocols.

　　Actively engaging in industry forums, you will drive external partnerships, benchmark, and implement best practices. Additionally, you will assign projects and initiatives in collaboration with the Global Distribution Operations and Transformation lead.

　　In this vital role, you will :

　　Provide daily guidance and support to Production staff in regard to compliance with Standard Operating Procedures and Work Instructions.

　　Act as a first point of contact in case of production queries (quality-related) during packaging and labeling operations.

　　Review and approve batch production record data entries before production activities take place

　　Perform finished product checks during (commercial) production runs.

　　Compile and review batch records for lots assembled, packaged, and labeled at ABR and contract manufacturers in preparation for disposition by QP.

　　Participate in on-the-job training activities to explore the responsibilities of QP.

　　Act as author for operational SOP’s and Work Instructions.

　　Review operational SOP’s and Work Instructions, and review and approve deviation records.

　　Initiate and own deviations as needed and approve Maximo Work Orders.

　　Review and approve test protocols before use in production and perform GMP compliance checks in production.

　　Assist in the development and delivery of GMP training activities for QA and production staff.

　　Participate in QA production-related projects as needed

　　Assist in various investigations, ABR projects, and improvement efforts as needed;

　　Responsible for the preparation of weekly/monthly metrics.

　　Own and maintain departmental performance boards.

　　Operate in shifts

　　WIN

　　What we expect of you

　　We are all different, yet we all use our outsanding contributions to serve patients. The Sr. Associate Plant QA – Trainee QP professional we seek is a problem solver with these qualifications:

　　Master in Science degree, preferably in Life Sciences or a related field.

　　Ability to fulfill the requirements of EU directive 2001/83/EC article 49 (Qualified Person) after training.

　　Typically 1-2 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations.

　　Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases.

　　Affinity with Manufacturing and/or Quality analytical processes and operations.

　　Proficient in English language.

　　THRIVE

　　What you can expect of us

　　As we work to develop treatments that look after of others, we work to care for our teammates’ professional and personal growth and well-being.

　　Vast opportunities to learn and move up and across our global organization.

　　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, a vitality program, and a restaurant with balanced food.