Amgen is seeking an IT Quality-Specialist to lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. The individual will supervise validation activities, conduct risk assessments, 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
- 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
- Design clear, engaging charts and graphics for presentations and reports
- Utilize tools like Power BI, Smartsheet, or similar to develop interactive, data-driven visuals
- Translate complex data into concise, compelling visual stories for diverse audiences
- Collaborate with cross-functional teams to align visual outputs with business goals
Benefits
- Competitive and comprehensive Total Rewards Plans
- Equal Opportunity employer
- Reasonable accommodation for individuals with disabilities
- Support for professional and personal growth and well-being
- Collaborative culture
