What are the responsibilities and job description for the Quality Assurance Specialist position at Careers Integrated Resources Inc?
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.
DESIRED MINIMUM QUALIFICATIONS
- 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