Associate- Quality Complaints

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Lets do this. Lets change the world. 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

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

• Bachelors degree and 2 to 4 years of in Pharma/Life Sciences/Biotechnology
• OR Masters and 1- 3 years of in Pharma/Life Sciences/Biotechnology Experience

• Quality and/or manufacturing experience in biotech, medical device or pharmaceutical industry
• Ability to successfully manage workload to timelines
• Ability to operate in a matrixed or team environment with site, functional, and senior management leadership
• Understanding of quality and industry requirements/expectations of a QMS
• Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
• 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
• Practical experience with and knowledge of MS Office Applications (e.g. Microsoft Word, Excel)
• Verbal and written communication skills/writing skills
• Technical Learning Skills - ability and willingness to learn new technologies, processes, and methodologies.
• Active listening skills
• Ability to understand and follow processes / process instructions
• Attention to detail