Associate Quality Complaints

Amgen is hiring for the role of Associate Quality Complaints!

About Amgen:

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing, and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. 

Requirements:

• Basic to intermediate understanding of tools such as Smartsheet and Veeva to support the development and management of documents, business/system processes, and related data.
• Knowledge of Microsoft Copilot, OpenAI ChatGPT, and other AI/Large Language Model (LLM) tools.
• Understanding of key regulations (e.g., EMA, FDA) and ethical guidelines (GxP) governing the pharmaceutical industry.
• Proper utilization of process management systems (e.g., Amgen CDOCS for controlled documents or Amgen Learning Management System (LMS)) to process materials, including the creation and distribution of status reports.
• Experience in at least one of the following areas: Quality Management, Document Management, Quality Assurance, Learning Management, or Learning Management Systems (LMS).
• Practical experience with and knowledge of MS Office applications (e.g., Microsoft Word, Excel, Visio).
• Practical experience in managing projects/multiple projects simultaneously.
• Strong verbal and written communication skills, including writing skills.
• Process/business writing skills.
• Technical learning skills with a willingness to learn new technologies, processes, and methodologies.
• Active listening skills.
• Critical, problem-solving, logical thinking skills, and process-oriented mindset.
• Ability to understand and follow processes/process instructions.
• Attention to detail.
• Ability to translate business and stakeholder feedback and requirements into accurate and efficient processes using clear language and format.