Sr Associate Plant QA (2x)

Career Category

Quality

Job Description

If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its 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 countries around the world. Every day more than 1000 people from 38 different nationalities work across supply chain manufacturing commercial operations and clinical research to ensure patients receive life-changing medicines.

LIVE

What you will do

As a Sr Associate Plant QA you will play a key role in supporting manufacturing operations by providing real-time Quality Assurance guidance throughout packaging and labeling activities. This role is performed on a shift rotating schedule and includes a 25.1% shift allowance as part of the compensation package.

You will help ensure that products are manufactured documented and released in full compliance with GMP requirements while partnering closely with Production and other cross-functional teams. You will perform Quality Pack Checks review batch documentation support investigations and contribute to continuous improvement initiatives that strengthen quality compliance and operational performance.

In this highly collaborative role you will build strong working relationships with Production Operators Line Leads Shift Supervisors Warehouse Maintenance & Engineering Technical QA and Qualified Persons (QPs) acting as a trusted quality partner on the production floor.

Are you ready Lets do this. Lets change the world.

In this vital role you will:

• Provide day-to-day QA guidance and support to Production teams ensuring compliance with Standard Operating Procedures (SOPs) Work Instructions and GMP requirements.
• Act as the first point of contact for quality-related questions during packaging and labeling operations.
• Review and approve batch production record entries before manufacturing activities begin.
• Perform Quality Pack Checks and finished product inspections during commercial production runs.
• Compile review and verify batch records for products assembled packaged and labeled at Amgen Breda (ABR) and contract manufacturing sites in preparation for Qualified Person (QP) disposition.
• Review and approve deviation records ensuring investigations are completed accurately and in a timely manner.
• Partner with cross-functional teams to resolve quality-related issues and support the implementation of effective corrective and preventive actions (CAPAs).
• Support QA-related projects system improvements and continuous improvement initiatives that enhance compliance and operational excellence.

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 collaborative detail-oriented quality professional who enjoys working in a dynamic manufacturing environment.

Basic Qualifications:

• Bachelors degree in Life Sciences or a related scientific discipline or an equivalent combination of education and relevant experience.
• Approximately three years of Quality Assurance or pharmaceutical manufacturing experience within a GMP-regulated environment.
• Experience with batch record review deviation management and quality investigations.
• Solid knowledge of Good Manufacturing Practice (GMP) Good Distribution Practice (GDP) and/or Good Clinical Practice (GCP) with the ability to apply quality principles in day-to-day operations.
• Understanding of pharmaceutical manufacturing processes and quality systems.
• Strong attention to detail analytical thinking and problem-solving skills.
• Excellent communication and collaboration skills with the ability to build effective working relationships across multiple functions.
• Fluency in English both written and spoken.

THRIVE

What you can expect of us

As we work to develop treatments that take care of others we also invest in our teammates professional and personal growth.

• Vast opportunities to learn develop and grow your career across our global organization.
• A diverse and inclusive workplace where everyone is empowered to contribute innovate and make a difference.
• A competitive Total Rewards package including an attractive salary 25.1% shift allowance annual bonus fixed 13th month holiday allowance and collective health insurance.
• A strong focus on well-being with an on-site gym vitality program and a restaurant offering healthy meal options.

.

Required Experience:

Senior IC

Employment Type : Full-Time
Experience: years
Vacancy: 1