[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.

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