Associate Quality Complaints

*What you will do*

In this vital role you will own 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 critical issue for further higher level investigation.

• Evaluates and ensures triaged product complaint records stay in sync 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
• Completes assigned assessments per applicable procedures
• Ensures quality of complaint records
• Drives the complaint process per SOP requirements
• Owns or handles 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 results within time and with encouraged quality, including (but not limited to) proactive written / in person communication, status updates, tracker & tool maintenance

*What we expect of you*

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

Basic Qualifications:

• Bachelors degree and 0 to 3 years of Data Sciences, Biochemistry, Chemical Engineering or other Sciences' experience OR
• Diploma and 4 to 7 years of Data Sciences, Biochemistry, Chemical Engineering or other Sciences' experience

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
• Accurate 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 handling 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 key collaborator feedback and requirements into accurate and efficient processes using clear language and format