Full-time
Quality Assurance Risk Management Specialist - EPM Scientific - Portsmouth, NH

Our client is one of the most reputable global CDMO's in the entire world that is renowned for accelerating career growth for their employees. Located in Portsmouth NH, they have one of the largest cell therapy manufacturing facilities in the entire world, and provide manufacturing services for some of the most reputable clients in the industry.The Quality Risk Management Specialist is responsible for assisting with management and continuous improvement of the Quality Risk Management Program for the Portsmouth facility according to International Conference on Hormonisation (ICH) Q9 and other applicable regulatory guidance. The Quality Risk Management Specialist must effectively work with departments to provide training, technical support and expertise with Quality Risk Management principles and application.Key responsibilities:Work with departments to provide technical support and expertise with the Quality Risk Management Program.Provide support in all aspects of risk management (planning activities, tool selection/application, facilitation, and consultation).Work with department(s) to understand their project/Quality Risk Management requirements and assist with risk management solutionAssist with Quality Risk Management integration (departmental case studies)Support Global initiatives where Quality Risk Management support is required.Reflect on executed risk assessment activities to optimize future assessment activities/projects.Select/adapt Quality Risk Management tools to fit departmental Quality Risk Management requirements that is defendable (audit and inspection)Identify and evaluate advanced tools for application at the site Hazardous Analysis Critical Control Points (HACCP) and establish and deliver training material.Review Quality Risk Management reports where facilitated and/or support is required to comply with Quality Risk Management procedure/programAssist with the management and continuous improvement of the Quality Risk Management program including creation of Quality Risk Management training material and delivery to personnel.Conduct monthly general Quality Risk Management facility training.Maintain established training material and establish/deliver new training modules for the Quality Risk Management program.Defend Quality Risk Management Program during internal and external auditsPerform other duties as assigned.Key requirements:Bachelors Degree or equivalent work experience in the SciencesAdvanced Years of experience in a Good Manufacturing Practices (GMP) environment with a specific focus on Quality Risk Management and application/use of Quality Risk Management toolsPrefer Yellow/Green/Black BeltPrefer American Society for Quality (ASQ) CertificationJob Type: Full-timeSalary: $80,000.00 to $100,000.00 /yearAdditional Compensation:BonusesWork Location:One location

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