Amgen - Associate - Product Quality Compliance - Data Verification

About Amgen:

Amgen harnesses the best of biology and technology to fight the worlds toughest diseases, and make peoples 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 whats known today.

About the Role:

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 Amgens compliance practices for late-stage and commercial products by reviewing critical data and documents to confirm accuracy, integrity, and regulatory readiness.

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:

- Bachelor's/Masters degree with minimum of 3 years of pharmaceutical industry or directly related experience.

Functional 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.

What Success Looks Like:

- 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.

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