- Experience working with large volumes of product complaint records,
- experience with combination products,
- experience with investigation process – RCA (candidate should be able to provide examples that included the key stages in an investigation), and
- tangible examples of escalation process and working with priorities.
- e team is seeking a Specialist Quality Complaints Owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and executes 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.
- The Specialist conducts facilitates cross-functional teams to conduct complex complaint investigations, determines corrective actions with their effectiveness and determines the steps necessary to ensure the proper level of control for product in distribution. Aligns complaint closure requirements in adherence with pre-determined process step metrics to ensure timely closure of records.
- Ensures quality of complaint records
- Facilitate cross-functional meetings to plan and coordinate the plan for closure of records
- Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information
- Executes against prioritized work plans
- Quickly escalates issues that could impede the ability to close records according to action plans
- Maintains compliance with local and global processes
- Execution of regulatory and SOP requirements
- Anticipates and prevents potential issues with regulators
- Provides guidance and technical advice
- Evaluates subject matter expert assessments
- Escalates potential Quality issues to Management
Master’s degree & 3 years of Quality / Manufacturing experience
Bachelor’s degree & 5 years of Quality / Manufacturing experience
Associate’s degree & 10 years of Quality / Manufacturing experience
High school diploma / GED & 12 years of Quality / Manufacturing experience
- 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
- Bachelor’s Degree in a Science Field
- Ability to oversee multiple projects simultaneously
- Ability to successfully manage 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)
"This posting is for Contingent Worker, not an FTE"