Quality Assurance Specialist

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Review all electronic documents submitted to document control for correct formatting, spelling and clarity of text before releasing as approved documents
• Maintains revision and approval status of all documents
• Maintains hard copies of all approved documentation
• Maintains appropriate form templates for access
• Updates computerized documents with data from change control documents and maintains archive of changed ISO/FDA controlled documents
• Manages circulation of documents for management approval
• Tracking, follow-up and implementation of, including but not limited to, ECOs, DCOs, MCOs, ECRs and DCRs.

• Minimum of 1-2 years' experience in document management using electronic document management systems or with manual systems using electronic document storage
• Minimum of 1-2 years' experience in a Quality Systems / Regulatory Compliance environment with a working knowledge preferably in the medical device, diagnostics or pharmaceutical industries.
• Familiarity with FDA regulations and ISO series of quality standards preferred
• Capable of both written and verbal effective communication skills including presentations as assigned.
• Proficient in the Microsoft Office suite of products
• Proficient in Agile Document Management System