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 innovative 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.
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:
Don't want to miss the next one?
Subscribe to daily email alerts for roles matching your interests.
Bachelor's/Master’s degree with minimum of 3 years of pharmaceutical industry or directly related experience
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-quality results using GMP systems
Excellent written and verbal communication skills
Good-to-Have Skills:
Knowledge of FDA and ICH regulations
Experience working in cross-functional, virtual teams across time zones
Familiarity with GMP applications such as Veeva, Spotfire, SampleManager LIMS
Proficiency in MS Office (Word, Excel, PowerPoint, Teams)
Soft Skills:
Strong initiative and self-motivation
Team-oriented mindset with focus on achieving shared goals
Ability to work effectively in diverse, global, virtual environments
What Success Looks Like
In this role, success will be demonstrated by:
Timely and accurate completion of document reviews and compliance activities
Proactive collaboration with cross-functional teams to meet project timelines
Effective use of GMP systems to maintain compliance and data integrity
Growth & Development
Amgen invests in employee growth. In this role, you will receive structured training on GMP systems and mentoring to develop your compliance expertise.
EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer. We will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We are committed to providing reasonable accommodation for individuals with disabilities during the application and interview process, in performing essential job functions, and in accessing employment benefits. Please contact us to request accommodation.
.
Similar roles you might like
More openings like this one — take a look before you go.
