Specialist, Quality – Document Control and Training

Responsibilities

• Support execution of document control activities including accuracy, formatting, and issuing/reconciling Controlled Documents
• Provide end user support for business processes and electronic document management system (eDMS) navigation
• Support the document archive program and maintain the archive database
• Provide eDMS, Document Control, and training support during Audits/Inspections
• Support the Training Program by managing Curriculum Assignments in LMS and distributing training reports
• Assist with execution of Test Scripts for validation testing of electronic quality systems and LMS enhancements
• Act as a subject matter expert for electronic document management systems
• Develop and implement ways to simplify business processes and documentation strategies

Requirements

• 3-5 years of experience in a regulated life science industry
• Bachelor's degree
• Direct experience in document control, quality systems, and/or training
• Proficiency with Microsoft Office suite (Word, PowerPoint, Excel, Outlook, SharePoint)
• Strong attention to detail and ability to work in a fast-paced environment

Preferred Qualifications

• Experience in Veeva Vaults
• Knowledge of US and EU cGMP regulations and guidance

About the Company

Kiniksa Pharmaceuticals is a commercial-stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications.