Join our team at AMGEN Capability Center Portugal, the number 1 company in Best Workplaces - https://www.greatplacetowork.pt/ - ranking in Portugal (category 201-500 employees) by the Great Place to Work Institute. We have a growing team of 340 talented people and more than 35 different nationalities, diverse areas of expertise, and professional experience shaping the future of healthcare. This is your chance to explore a world of opportunities in different areas such as Cybersecurity, Data & Analytics, Digital, Technology and Innovation, Finance, General & Admin, Human Resources, Regulatory Affairs and many more. Based in Lisbon's city center, our AMGEN office feeds innovation, excellence, and inspiration. Come thrive with us at AMGEN, supporting our mission To Serve Patients.
SR ASSOCIATE QUALITY COMPLIANCE
WHAT YOU WILL DO
Let’s do this. Let’s change the world. In this vital role, the Sr. Associate Quality Compliance will support the R&D quality organization and the Process Document Management (PDM) team by providing expert support for creating and managing R&D-controlled processes and documents. The team is responsible for maintaining R&D standards and contributing to the compliant execution of R&D processes through clear and appropriate controlled documentation. The PDM team also provides R&D oversight for the electronic document management system, including enhancements and improvements.
The Sr. Associate Quality Compliance under general guidance 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 results within time and with expected quality, including proactive written/in person communication, status updates, tracker & tool maintenance.
* Lead discussions with subject matter experts in the business and stakeholders and other quality functions to facilitate dialog and review of materials and to transform feedback into controlled documents/procedures, process model flows, or learning related content.
* Accurate utilization of process management systems (e.g. Amgen CDOCS for controlled documents or Amgen Learning Management System LMS) to process materials; creation & distribution of status reports.
WHAT WE EXPECT OF YOU
We are different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.
Qualification:
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/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.
* Proficiency in verbal and written English to be able to understand & articulate technical concepts.
WHAT CAN YOU EXPECT FROM US
* Vast opportunities to learn, develop, and move up and across our global organization.
* A diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act.
* Generous Amgen Total Rewards Plan comprising healthcare, finance, wealth, and career benefits.
* Flexible work arrangements.
APPLY NOW
Objects in your future are closer than they appear. Join us.
CAREERS.AMGEN.COM
EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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