Job Description
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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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