Quality Systems Specialist

The Specialist will be a primary partner on:  

Working closely with the Senior Manager of Quality Assurance and other Quality Systems Specialists, the Specialist will be instrumental in engaging the site in performing investigations, change plan development and change action and CAPA fulfillment, and leading the assessments for risk against validated systems and process states, and impact to product quality and safety.  

 

The Specialist will work directly with Project Management in acting as Quality liaison with Client Quality Units. They will coordinate site SMEs in Client engagement to ensure Quality Event timelines are met in the furtherance of product quality and release assurances.    

The Specialist will exemplify excellent interpersonal skills and be capable of developing productive customer-centric working relationships with internal and external customers and have a role with high visibility to all departments.  The Specialist will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences.  The Specialist will have strong familiarity with industry standard Deviation/investigation, root cause assessment, risk assessment, change management, and CAPA processes.  The Specialist will have familiarity with electronic Quality Management System(s) and Microsoft Office suite products, and the development of process metrics.  They will thrive in a team environment, but will also work autonomously utilizing strong self-management and organizational skills.  The Specialist will value the processes owned by internal customers and subject matter experts and will possess a demonstrated ability to support and influence positive outcomes in the application of that knowledge to wider processes.