Associate Quality Complaints

Overview

Own and implement Amgen's end-to-end global complaint process and management system, keeping complaint processes compliant with quality operating standards and translating market information into continuous improvement.

What you'll do

• Conduct complaint investigation tasks for customer feedback records, including records with limited information and records that may not require investigation.
• Determine whether complaint investigations require escalation as a critical issue for higher-level investigation.
• Evaluate and ensure triaged product complaint records stay in sync with applicable procedures.
• Evaluate and manage customer feedback records to closure.
• Evaluate records determined to be voided and complete the void process.
• Own records with limited information.
• Complete assigned assessments per applicable procedures.
• Ensure quality of complaint records.
• Drive the complaint process per SOP requirements.
• Own or handle the review and approval process flow in CDOCS for controlled documents, adhering to format, content, style guidelines, usability, accuracy, consistency and quality according to templates and style guide.
• Support management of assigned projects or project tasks to achieve agreed results within time and with encouraged quality, including proactive written and in-person communication, status updates, and tracker and tool maintenance.

What you'll need

• Bachelor's degree and 3 to 4 years of experience in Pharma/Life Sciences/Biotechnology/Engineering, OR Master's degree and 2-4 years of experience in Pharma/Life Sciences/Biotechnology/Engineering.
• Candidates with an Engineering qualification must possess prior experience handling product quality complaints in the pharma or medical devices industry.

Nice to have

• 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 applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes).
• Accurate utilization of process management systems (e.g., Amgen CDOCS for controlled documents or Amgen Learning Management System LMS) to process materials, and creation and distribution of status reports.
• Practical experience with and knowledge of MS Office applications (e.g., Microsoft Word, Excel).
• Verbal and written communication skills.
• Technical learning skills: ability and willingness to learn new technologies, processes, and methodologies.
• Active listening skills.
• Ability to understand and follow processes and process instructions.
• Attention to detail.