R&d Quality

2 semanas atrás

Lisboa, Lisboa, Portugal Amgen Tempo inteiro

R&D Quality & Performance Associate

LIVE

WHAT YOU WILL DO
This role is under general guidance, the R&D Quality & Performance Associate will work in document management, business process modelling and learning content management with the following primary responsibilities:

  • 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
  • Contributes actively on the development of supplemental learning materials
  • Supports 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

WIN

WHAT WE EXPECT OF YOU

Qualification:

University Degree in Biochemistry, Chemical Engineering or other Sciences
At least 2 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.

THRIVE

WHAT YOU CAN EXPECT OF US


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.

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