Senior Associate QC - Quality Control Systems - Remote

Overview

Amgen is seeking a Senior Associate to support the Electronic Lab Notebook (ELN) and consumable inventory system infrastructure in the Quality Control (QC) network, primarily working from our office in Hyderabad, India, with responsibilities that include creating and revising templates for analytical method executions.

In Short

• Support ELN and consumable inventory systems in QC.
• Create, revise, and qualify templates for analytical methods.
• Collaborate with US-based Master Data Group.
• Coordinate with site representatives and other template builders.
• Demonstrate proficiency in virtual communication tools.
• Manage remote collaborations effectively.
• Cross-train in LIMS, Empower, and Chromeleon.
• Ensure compliance with QC standardization procedures.
• Provide performance metrics and drive QC system alignment.
• Work a shift-based schedule to support global operations.

Requirements

• Master's degree with 3-6 years of experience in Pharma/Biotech QC.
• Proficiency in ELN applications.
• Knowledge of Data Integrity requirements for QC systems.
• Excellent verbal and written communication skills in English.
• Problem-solving and troubleshooting abilities.
• Independence in delivering quality results.
• Familiarity with Good Manufacturing Practices.
• QC lab testing experience.
• Microsoft Office proficiency.
• Ability to convert QC source documents into ELN templates accurately.

Benefits

• Opportunity to work with a leading biotechnology company.
• Engagement in innovative medicine development.
• Supportive and inclusive work environment.
• Career growth opportunities in a global company.
• Access to advanced tools and technology in biotech.