This role involves providing QA guidance to production staff and performing Quality Batch Record Reviews for all commercial batches at the AOH facility
Job Summary
This role involves providing QA guidance to production staff and performing Quality Batch Record Reviews for all commercial batches at the AOH facility.
The successful candidate will act as a first point of contact for quality-related queries during packaging and labeling operations while ensuring compliance with Standard Operating Procedures.
Amgen offers a comprehensive benefits package including retirement plans, health coverage, and opportunities for career development within a collaborative, science-based culture.
Matching Summary
This role involves providing QA guidance to production staff and performing Quality Batch Record Reviews for all commercial batches at the AOH facility.
Salary
Base: $82,081.95 - $111,052.05 USD annually; Bonus/Equity: Discretionary annual bonus program and stock-based long-term incentives available; Benefits: Comprehensive health, dental, vision, retirement plan, and flexible work models
Skills & Requirements
Must-have
4 years Quality or GMP Manufacturing experience
Review and approve batch production records
Monitor GMP operations in device assembly areas
Lead quality culture with production staff
Review Deviation, CAPA, and Change Control records
Nice-to-have
Scientific degree in Life Sciences or Engineering
Experience with SAP, TrackWise, or CDOCS software
Affinity with digital innovation and data sciences
Strong verbal and written communication skills
Experience with raw material receipt and sampling
Key Requirements
High school/GED plus 4 years Quality/GMP experience OR Associate's plus 2 years OR Bachelor's plus 6 months
Direct experience with Enterprise Resource Management software like SAP or TrackWise