IT Quality-Specialist

Join Amgen’s Mission of Serving Patients. As an IT Quality-Specialist, you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. You will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation.

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)

Benefits

• Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards