Specialist Quality Complaints

We are seeking a Specialist Quality Complaints Complaint Owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

• Ensures quality of complaint records
• Applies analytical abilities to evaluate complex situations using multiple sources of information
• Execution of regulatory and SOP requirements
• Anticipates and prevents potential issues with regulators
• Provides guidance and technical advice
• Evaluates subject matter expert assessments
• Raises potential Quality issues to Management

What we expect of you

Basic Qualifications:

• Doctorate degree OR

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• Master s degree and 4 to 6 years of Specialist Quality Complaints experience OR

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• Bachelor s degree and 6 to 8 years of Specialist Quality Complaints experience OR

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• Diploma and 10 to 12 years of Specialist Quality Complaints experience

Preferred Qualifications:

• Quality and manufacturing experience in biotech or pharmaceutical industry
• Ability to oversee multiple projects simultaneously
• Ability to successfully handle workload to timelines
• Familiarity with basic project management tools
• Ability to negotiate a position after taking feedback from multiple sources
• Demonstrated ability to consistently deliver on-time, and high-quality results
• Ability to operate in a matrixed or team environment
• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)