Associate Product Quality Specialist - Data Verification

Associate Product Quality - Data Verification

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 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.

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-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.

.

Experience Level

Mid Level