Associate Quality Complaints

Career Category

Quality

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What you will do

Amgen is seeking an 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 resolves if complaint investigations require critical issue for further higher level investigation.

Responsibilities:

• Evaluates and ensures triaged product complaint records align 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
• Implements 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 work within time and with expected quality, including (but not limited to) proactive written / in person communication, status updates, tracker & tool maintenance

What we expect of you

Basic Qualifications:

• Bachelor’s degree in Data Sciences, Biochemistry, Chemical Engineering or other Sciences and 0 to 3 years in the pharmaceutical, biotech, medical devices or healthcare industry or a Contract Research Organization OR
• Diploma and 4 to 7 years of relevant 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
• 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 leading 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 an