Sr Associate Plant QA

Career Category

Quality

Job Description

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.

LIVE

What you will do

As Sr Associate Plant QA, you will be working in 3 shift and you will be mainly responsible for providing QA guidance and support to ABR production.

Besides that, you will be performing Quality Pack Checks and Batch Record Reviews of all commercial batches labeled and packed at ABR. Next to that, you will provide support in different QA-related projects/systems.

In this role, you will be in direct contact with a wide range of stakeholders, and you will be responsible for establishing effective working relationships with production operators, production line leads, production shift supervisors, warehouse, maintenance and engineering, technical QA, and the Qualified Person.

Are you ready? Let’s do this. Let’s change the world.

In this vital role, you will:

• 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.

WIN

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Sr Associate Plant QA professional we seek is a collaborator eye detailed with these qualifications:

• 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.
• Fluent in the English language.

THRIVE

What you can expect of us

As we work to develop treatments that take care of others, so 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 healthy food.

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