Senior Analyst Quality Control - Physicochemical - Remote

Overview

As a Senior Analyst in Quality Control at Amgen, you will play a vital role in ensuring the quality of products through physicochemical analysis and compliance with regulatory standards.

In Short

• Conduct quality control analysis of products.
• Participate in analytical transfers of new products.
• Create, review, and maintain GMP documentation.
• Manage laboratory supply consumption and purchases.
• Execute validation activities as per the Master Validation Plan.
• Handle quality systems including deviations and CAPA.
• Participate in internal and regulatory audits.
• Provide GMP training as required.
• Support Quality Assurance and Logistics areas.
• Investigate out-of-specification results.

Requirements

• Bachelor's degree in Pharmacy, Biochemistry, Biotechnology, Chemistry, or related Health Sciences.
• 5 years of experience in Quality Control laboratories.
• Experience with physicochemical analysis and HPLC (mandatory).
• Intermediate to advanced English proficiency.
• Experience in microbiology (desirable).
• Knowledge of quality systems and regulations (GXP).
• Familiarity with analytical method transfer and compendial methods.
• Proficient in MS Office tools.
• Strong understanding of GXP regulations.
• Experience in qualification/validation in quality control.

Benefits

• Opportunities for professional growth and learning.
• A diverse and inclusive community.
• Reward programs and benefits.
• Supportive work culture focused on patient care.
• Global opportunities within the organization.