Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver cutting-edge medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.
About The Role
Role Description:
The Associate Quality Compliance is an individual contributor role that plays a vital part in supporting Product Quality Teams (PQTs). This role ensures adherence to Amgen’s compliance practices for late-stage and commercial products by reviewing critical data and documents to confirm accuracy, integrity, and regulatory readiness.
Through diligent verification, navigation of GMP-compliant systems, and close collaboration across global teams, you will help ensure Amgen continues to deliver products of the highest quality and safety.
Roles & Responsibilities
• Execute transactions in GMP computer-based systems (e.g.,
Veeva, LIMS).
• Review and verify data in technical documents within GMP Quality systems.
• Navigate GMP systems (Spotfire, Veeva, SampleManager LIMS) to identify and validate data sources.
• Manage time-sensitive compliance activities across multiple teams and projects independently.
• Collaborate with document authors across sites and time zones to support project milestones.
• Provide guidance and feedback to authors of GMP documents to ensure compliance and accuracy.
Basic Qualifications And Experience
• Bachelor's/Master’s degree with minimum of 3 years of pharmaceutical industry or directly related experience
Functional Skills
Must-Have Skills:
• General knowledge of GMP principles and pharmaceutical industry standards for Quality
• Robust organization skills with high attention to detail
• Ability to meet deadlines and deliver high-quality results using GMP systems
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