IT Quality-Specialist

Join Amgen’s Mission of Serving Patients. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Requirements

• Master’s degree with a minimum of 7 years experience in Software and Systems Quality assurance OR Bachelor’s degree with a minimum of 10 years of Software and Systems Quality assurance experience
• Strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards
• Proven experience in the validation of computerized systems (GxP)
• Strong understanding and application of GxP regulations (GMP, GLP, GCP, GPvP, GDP)
• Experience managing quality assurance processes, including Major and Minor Deviations
• Demonstrated ability to handle and resolve complex quality issues using analytical and problem-solving skills
• Strong decision-making abilities with the capacity to drive tasks to completion
• Ability to work independently with minimal supervision
• Leadership skills with experience leading projects, teams, or tasks
• Experience with tools and systems such as HP ALM, Jira, Confluence, Track Wise, Documentation Management Systems, LIMS, SAP and Maximo
• Broad technical expertise within specialty area and familiarity with industry standards
• Ability to provide training, guidance, and contribute to team quality
• Works closely with senior staff and external experts to extend capabilities and enhance performance
• Data analysis skills (Good to have) - Perform data analysis to create impactful visuals and dashboards for informed decision-making

Benefits

• Competitive benefits
• Comprehensive Total Rewards Plans
• Collaborative culture
• Professional and personal growth and well-being