Website Amgen ltd
Post Name: Associate Quality Complaints
What you will do:
Let’s do this. Let’s 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
What we expect from you:
We are all different, yet we all use our unique contributions to serve patients.
Basic Qualifications:
Bachelor’s degree and 3 to 5 years of in Pharma/Life Sciences/Biotechnology
OR
Master’s degree and 2- 4 years of in Pharma/Life Sciences/Biotechnology Experience
Preferred Qualifications:
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
What you can expect of us:
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
