Global Quality Systems Analyst

Job Description

The Global Quality Systems Change Analyst assists in the review, release, and implementation of global quality documents via the change order process. The GQS Change Analyst ensures documentation and record keeping processes conform to all applicable internal procedures and external medical device regulatory requirements. The individual will assist in the day-to-day document control activities within the Global Quality Systems documentation team. Essential functions include at a minimum: 
• Performs document control functions by initiating change orders to effectively route, track, process, review, distribute, release, and archive documents 
• Collaborates with cross-functional teams and Global Process Owners in the timely release of documents via the change order process 
• Organizes and ensures accurate and reliable document requests using SharePoint 
• Provides a thorough review of document content prior to routing to ensure adherence to internal processes 
• Works closely with translation agency to coordinate document translations 
• Adheres to internal processes and provides input for process improvement 
• Proactively initiates, develops, and maintains effective working relationships with team members 

Qualifications

• Bachelor’s degree in scientific discipline or an equivalent combination of skills, education, and experience 
• Quality professional with 3-5 years of experience with document management in a regulated industry – pharmaceutical or medical device industry – with direct document control and change order system experience 
• Excellent analytical, verbal communication and writing skills 
• Self-starter able to manage multiple competing demands 
• Proficient at reviewing and editing documentation 
• High-level critical thinking and problem-solving skills 
• Skilled in the use of a Product Lifecycle Management (PLM) system, MS office applications such as Word, Excel, PowerPoint and Adobe Acrobat 
• Self-motivated with ability to implement, organize and prioritize multiple tasks to meet deadlines 
• Ability to effectively build and maintain relationships with all levels of management 
• Knowledge of industry regulations to include 21 CFR 11, ISO 13485, ISO 9001, Good Documentation Practice (GDP) 
Preferred Skills 
• Technical writing or copy-editing background 
Experience working with translations and localization of written content

Additional Information

Regards,
Monil Patel
Technical Recruiter
Integrated Resources, Inc
(732) 844-8747 Ext.338
monil  @irionline.com