[Hiring] Specialist Quality Complaints @Amgen

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description Join Amgen’s Mission of Serving Patients. In this vital role you will: • 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 determine steps necessary to ensure the 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, ensuring a thorough and strategic approach to issue resolution. Qualifications • Master’s degree (or foreign equivalent) in Industrial Engineering or related field. • 2 years of experience in the job offered or in an engineering-related occupation. • Experience in manufacturing testing processes, including API, Drug Substance, Drug Product, Packaging, and Device manufacturing processes. • Quality and manufacturing experience in biotech or pharmaceutical industry. • Experience with Quality Management Systems including Salesforce, Trackwise, or SAP. • Experience with Electronic Document Management Systems including Veeva Vault Quality, Box, and SharePoint. • Knowledge of global regulations including FDA 21 CFR 820, ISO 13485, FDA cGMP, and Device cGMP Regulations. • Proficiency in operating project management tools including Microsoft Office, Smartsheet, or Miro. • Experience in identifying and escalating Quality Defects, and communicating with contract manufacturing organizations or suppliers. Requirements • Master’s degree (or foreign equivalent) in Industrial Engineering or related field & 2 years of experience in the job offered or in an engineering-related occupation. • Position requires 2 years of experience in the following: • Manufacturing testing processes, including API, Drug Substance, Drug Product, Packaging, and Device manufacturing processes. • Quality and manufacturing experience in biotech or pharmaceutical industry. • Quality Management Systems including Salesforce, Trackwise, or SAP. • Electronic Document Management Systems including Veeva Vault Quality, Box, and SharePoint. • Global regulations including FDA 21 CFR 820, ISO 13485, FDA cGMP, and Device cGMP Regulations. • Operating project management tools including Microsoft Office, Smartsheet, or Miro. • Identifying and escalating Quality Defects, and communicating with contract manufacturing organizations or suppliers. Benefits • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions. • Group medical, dental and vision coverage. • Life and disability insurance. • Flexible spending accounts. • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan. • Stock-based long-term incentives. • Award-winning time-off plans. • Flexible work models, including remote and hybrid work arrangements, where possible.