Senior Specialist QA-External Product Complaints
This position will be responsible for leading FDA Medical Device Reporting, Periodic Benefit Risk Evaluation Reporting, Activities related to Regulatory information Requests, and External Supply Complaints overall Performance Monitoring.
The position will be responsible for triaging and investigating complaints integral to the design, manufacture, delivery and service of our products. Interact with and communicate with internal and external customers while meeting regulatory compliance and its required documentation. Investigate complaint records, process and close complaints while following company procedure.
Supporting the product complaint system at Amgen through; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner. Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately. Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations. Follow-up on corrective actions derived from investigations through completion. On occasion, depending on the nature and complexity of the complaint, the Sr Specialist may be responsible of conducting and documenting the investigation.
*Interact and communicate with internal and external customers for reporting of complaints and adverse events (this may include intake and/or follow -up requests for information.)
*Ensure that all complaints requiring customer responses are properly addressed as assigned.
*Understands the complaint handling process from initiation to closure.
*Process and close complaints in a timely manner.
*Maintain current knowledge of the Regulatory regulations
*Serves as an internal review in order to assure regulatory compliance across all product lines.
*Other duties as assigned.
Doctorate degree and 2 years of Quality or Operations experience
Master's degree and 6 years of Quality or Operations experience
Bachelor's degree and 8 years of Quality or Operations experience
Associate's degree and 10 years of Quality or Operations experience
High school diploma / GED and 12 years of Quality or Operations experience
Masters Degree and 6 years' experience in the Medical Device/Pharmaceutical Industry in GMP compliance and Quality Assurance.
FDA Medical Device Reporting, Periodic Benefit Risk Evaluation Reporting and Global Safety Experience
Product complaints management experience
Experiences in the medical devices and/or healthcare
Strong project management skills, experience leading cross-functional teams, and the ability to handle multiple projects simultaneously
Excellent written and verbal communication skills, including facilitation and presentation skills
Able to work in a team-oriented, matrix environment and work effectively with diverse departmental groups
Be self-motivated, able to interface effectively with various levels, attentive to details and able to prioritize and meet deadlines, and must possess excellent leadership, problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment
Computer literacy, independently understand, follow and implement instructions, work independently or as a team player and collaborate with outside resources, and the ability to evaluate issues, make decisions and determine when to escalate
Excellent writing skills that include closing the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers