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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. 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.
Job Responsibility
Provide daily guidance and support to Production staff regarding 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
Review and approve Deviation records
Requirements
Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience
Typically 3 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
Manufacturing and/or Quality analytical processes and operations