R&d Quality

6 meses atrás

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/problem-solving/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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