Career Category

Information Systems

Job Description

Description

Join Amgen's Mission to Serve Patients
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology
companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Sr Associate Data Scientist

Live

What will you do?

Amgen is seeking a Associate Quality Complaints owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

The Associate conducts complaint investigation tasks related to customer feedback records and records with limited information available, as well as records that might not require any investigation.  The Associate also determines if complaint investigations require escalation for further higher level investigation.

• Evaluates and ensures triaged product complaint records comply with applicable procedures

• Evaluates and manages customer feedback records to closure

• Evaluates records that have been determined to be voided and completes the void process 

• Owns records with limited information (with unknow batch/lot number, with no return unit available)

• Completes assigned assessments per applicable procedures

• Ensures quality of complaint records

• Executes the complaint process per SOP requirements

• Owns or manages the review/approval process flow in CDOCS of controlled documents; while adhering to format, content, and style guidelines, considering usability, and ensuring accuracy, consistency, and quality according to templates and style guide

• Supports management of assigned projects or project tasks 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

Win

What we expect of you?

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Bachelor Degree in Data Sciences, Biochemistry, Chemical Engineering or other Sciences

• At least 2 years of experience in the pharmaceutical, biotech, medical devices or healthcare industry or a Contract Research Organization

• Fluency in verbal and written English to be able to understand & articulate technical concepts

Preferred Qualifications:

• Basic to Intermediate 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.

• Understanding of key regulations (e.g. EMA, FDA) and ethical guidelines (GxP) governing the Pharmaceutical industry

• 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

• 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

Thrive

What can you expect of us?

• As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Vast opportunities to learn and move up and across our global organization

• In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com

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 reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits
and privileges of employment. Please contact us to request accommodation.

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