Senior Validation Associate

2 weeks ago


Holly Springs, United States BioSpace, Inc. Full time
About the Role
As a Commissioning and Qualification Expert at Amgen, you will play a vital role in ensuring quality and compliance are built into the new North Carolina facility from the start. This is an exciting opportunity for a motivated and organized individual to collaborate with cross-functional teams, providing quality support during execution of commissioning and qualification testing, reviewing and approving changes and discrepancies. You will ensure that all activities and related documentation for facilities, equipment, materials, and processes comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.

Job Description
In this challenging and rewarding role, you will perform quality review and approval of documents to support facility commissioning and qualification, according to project timelines. You will also provide quality assistance on quality records, including deviations/CAPAs, change controls and work orders, ensuring adherence to procedural requirements and confirming assessments and evaluations of different stakeholders are complete and accurate. Your ability to work in a team matrix environment and build relationships with partners will be essential in this role.

About the Team
Our team at Amgen is dedicated to developing treatments that take care of others. We foster an inclusive environment of diverse, ethical, committed, and highly accomplished people who respect each other and live the Amgen values. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team.

About the Location
The expected annual salary range for this role is $90,000 - $110,000. Additionally, we offer a comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

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