• R&d Quality Lisbon
  • Amgen in Lisbon, , Portugal
  • jobs
  • 2 days ago

jobs description

R&D Quality & Performance Senior Associate


This Role under general guidance, the R&D Quality & Performance Sr.

Associate will work in document management, business process modelling and learning content management with the following primary responsibilities:
• Lead the writing, review, revision, and formatting/QC of controlled documents and process models; while adhering to format, content, and style guidelines, considering usability, and ensuring accuracy, consistency, and quality according to templates and style guide
• Development of supplemental learning materials
• Management of assigned projects and stakeholders to achieve agreed deliverables within time and with expected quality, including (but not limited to) proactive written / in person communication, status updates, tracker & tool maintenance
• Proper utilization of process management systems (eg Amgen CDOCS for controlled documents or Amgen Learning Management System LMS) to process materials... creation & distribution of status reports




University Degree in Biochemistry, Chemical Engineering or other Sciences
At least 3-5 years of experience in the pharmaceutical / biotech industry or a Contract Research Organization

Required Skills:
• Understanding of key regulations (e.g. EMA, FDA) and ethical guidelines (GxP) governing the Pharmaceutical industry
• Experience in at least one of the following areas: Quality Management, Document Management, Quality Assurance, Learning Management / Learning Management Systems (LMS)
• Practical experience with and knowledge of MS Office Applications (e.g. Microsoft Word, Excel, Visio)
• Practical experience with managing projects / multiple projects at the same time
• Verbal and written communication skills/writing skills
• Process/business writing skills
• Technical Learning Skills ability and willingness to learn new technologies, processes, and methodologies.
• Active listening skills
• Critical/problemsolving/logical thinking skills and process oriented
• 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
• Fluency in verbal and written English to be able to understand & articulate technical concepts

Preferred skills:
• Intermediate to advanced understanding of other tools (e.g. Smartsheet, Veeva) to support the development and management of documents, business/system processes and related data.
• Knowledge of Microsoft copilot, open AI Chat GPT, and other AI/Large Language Model (LLM) tools.



As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Lisbon Portugal


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