About this role
Job title: Sr Associate Product Quality - Analytical
About the Role This is an individual contributor role that provides critical support to Product Quality Teams for late-stage clinical and commercial products. You will serve as a primary author of technical and regulatory reports, manage GMP data within compliant systems, and help ensure accuracy, completeness, and compliance across global submissions. You will also play an integral role in maintaining Amgen’s electronic databases and mapping tools, supporting continuous improvement initiatives, and providing peer training as needed. This role requires strong expertise in GMP compliance, technical writing, and cross-functional collaboration to drive high-quality outcomes under tight timelines.
What You'll Do
- Navigate and execute transactions in GMP systems (Empower, LIMS, Veeva, Spotfire).
- Work closely with in the Product Quality organization to drive standardization of data, and chromatographic overlay activities.
- Author and maintain GMP technical reports supporting regulatory filings within quality systems (e.g., Veeva).
- Collate, review, verify, and archive GMP data for late-stage clinical and commercial products.
- Ensure accuracy and completeness of product data with high attention to detail.
- Collaborate across global teams and time zones, effectively communicating findings and project updates.
What We're Looking For
- Master’s degree with minimum 6 years of Pharmaceutical/Biotechnology experience in Quality, Operations, Scientific, or Manufacturing fields.
- Must-Have Skills:
- Strong understanding of GMP requirements, US FDA, and ICH regulations
- Proven technical expertise in Chromatographic techniques/software and overlays
- Expertise in GMP systems (Veeva, Empower, LIMS, Spotfire)
- Strong data management, analytical, and problem-solving skills
- Experience supporting cross-functional teams in matrixed, global environments
- Proficiency in MS Office (Word, Excel, PowerPoint, Teams)
- Excellent written and verbal communication across all levels of the organization
- Continuous improvement mindset with experience applying lean practices
- 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 with minimal supervision
Nice to Have
- Knowledge of stability data management and annual product review
- Experience in assembling annual product reviews
- Experience in business process improvement and electronic data tool development
Compensation & Benefits
- Not disclosed in the posting