Specialist Quality Complaints

About This Role

Process product complaint records according to FDA guidelines and SOPs, providing technical guidance for complex investigations and ensuring quality closure of records. This role supports continuous improvement activities and acts as a Subject Matter Expert for device investigation reports within Amgen's mission of serving patients.

Responsibilities

• Ensure product complaint records are processed according to FDA guidelines, SOPs and other regulatory agencies guidelines
• Evaluate subject matter expert assessments
• Provide guidance and technical advice to conduct complex complaint investigations, determine corrective actions, and ensure proper level of control for product in distribution
• Ensure quality of complaint records and apply analytical abilities to evaluate complex situations using multiple sources of information
• Execute against prioritized work plans to ensure timely investigation and closure of records in adherence with pre-determined process step metrics
• Provide feedback and guidance to improve quality performance and prevent recurrence of issues
• Develop solutions to technical problems of moderate complexity
• Screen, evaluate, report and resolve record integrity issues
• Raise potential Quality issues to Management and intensify issues that could impede the ability to close records according to action plans
• Support department continuous improvement activities and projects in accordance with applicable regulations and business goals and objectives
• Serve as a Subject Matter Expert for the team, responsible for reviewing device investigation reports and ensuring proper investigation
• Support product hypercare by compiling and reviewing data
• Represent the electromechanical team and work with the AI pilot project for the complaints process optimization
• Direct discussions to define the scope of the Root Cause Analysis and Supplier Corrective Actions

Requirements

• 2 years of experience in manufacturing testing processes, including API, Drug Substance, Drug Product, Packaging, and Device manufacturing processes
• 2 years of experience in quality and manufacturing in biotech or pharmaceutical industry
• 2 years of experience with Quality Management Systems including Salesforce, Trackwise, or SAP
• 2 years of experience with Electronic Document Management Systems including Veeva Vault Quality, Box, and SharePoint
• 2 years of experience with global regulations including FDA 21 CFR 820, International Organization for Standardization ISO 13485, FDA cGMP, and Device cGMP Regulations to align with regulatory guidelines during processing product complaints
• 2 years of experience operating project management tools including Microsoft Office, Smartsheet, or Miro
• 2 years of experience identifying and escalating Quality Defects, and communicating with contract manufacturing organizations or suppliers

Qualifications

• Masters degree (or foreign equivalent) in Industrial Engineering or related field
• 2 years of experience in the job offered or in an engineering-related occupation

Skills

* Required skills

Benefits