The AIN Specialist QA plays a critical role in supporting product disposition tasks across the Amgen Quality Operations Network to serve patients living with serious illnesses
Job Summary
The AIN Specialist QA plays a critical role in supporting product disposition tasks across the Amgen Quality Operations Network to serve patients living with serious illnesses.
Key responsibilities include executing GMP processes for shelf-life extension, evaluating stability forms, and generating Certificates of Analysis for drug batches.
The candidate will lead remote support teams across multiple time zones while ensuring compliance with quality systems like SAP, LIMS, and CDOCS.
Matching Summary
The AIN Specialist QA plays a critical role in supporting product disposition tasks across the Amgen Quality Operations Network to serve patients living with serious illnesses.
Skills & Requirements
Must-have
GMP and GDP regulatory knowledge
SAP inventory management system experience
Batch record review in MES systems
Product expiry management processes
Certificate of Analysis generation
Nice-to-have
Project management experience
Data visualization with Tableau or Smartsheet
Cross-functional team leadership
Technical writing proficiency
Virtual training delivery skills
Key Requirements
Master's degree required
8-12 years Pharma/Biotech Quality experience
Experience in commercial or clinical manufacturing environments