Career Category
Quality
Job Description
ABOUT AMGEN
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
- Strong organization skills with high attention to detail
- Ability to meet deadlines and deliver high-q