Quality Risk Management Specialist

This role is part of the site's Quality Systems team and will primarily focus on maintaining the Quality risk management program at the Client Bothell manufacturing facility. The program is intended to promote self-identification of risk areas and implementation of risk mitigation measures for operations, cGMP compliance, and business continuity. Additionally, this role supports the use of various risk management tools to lead complex cross-functional issue resolution by employing a methodical approach to root cause analysis and implementing appropriate corrective and preventive actions.

• Contribute to the writing, coordination, review, and maintenance of the Bothell Risk Management Standard Operating Procedures (SOPs) and associated documents.
• Ensure product risk management documentation / files are maintained, with good documentation practices and in compliances with Client Quality System
• Facilitate planning, execution and completion of risk assessments by providing guidance to cross-functional team members
• Conduct risk reviews and escalate findings, as appropriate, to QRM team
• Track the status of risk mitigation actions through to completion
• Track the implementation of corrective actions associated with risk assessments and verify the actions are align with source event
• Responsible for maintaining the Bothell Quality Risk Catalog / Registry
• Support the creation, revision and approval of Quality Risk Management Reports
• Proactively deploy methods and techniques (e.g. Six Sigma / Lean, FMEA, Root Cause Analysis, etc.) to improve effectiveness of the Risk Management program.
• Collaborate to improve Quality Risk Methodologies and practices
• Generate data for Quality Risk Management Performance Metrics

Knowledge and Skills Required :