Quality Associate
Amgen deCODE genetics (ADG) is currently looking to fill a Quality Associate position, seeking a motivated individual with a strong interest in and relevant experience. Experience in lab environment is a requirement.
• Responsible for supporting the company’s quality management system
• Support collaborative partnerships with Research and Development (R&D) to help establish the state of quality and potential areas of quality risk exposure.
• Contribute to opportunities for improvement and support proactive quality oversight within the Research Organization.
• Manage regulatory inspections/Notified Body Audits and provide guidance and feedback on audit responses to health authorities, including root cause and CAPA plans.
• Partner on the execution of risk-based R&D audits.
• Track deliverables, monitor trends and provide data and recommendations regarding the state of quality for processes, technology, laboratory and external vendor performance.
• Maintain knowledge of current regulatory and subject matter areas of expertise as it pertains to site strategy.
• Follow-up on projects, participation in collaborative projects, and monitoring of processes
• University degree relevant to the position
• Experience in quality is preferred
• Prior experience working in or with Research laboratories required
• Ability to adapt to changing business needs
• Effective and timely decision making and influencing skills
• Good critical thinking and analytical skills
• Knowledge of the regulatory landscape including ISO 9001 and ISO 27001 and/or other ISO standards
• Knowledge of Inspection/Audit Management
• Positive attitude and strong interpersonal skills
• Initiative and ability to work independently
• Excellent written and spoken Icelandic and English are essential
• Very good general computer skills
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