The medical device manufacturer is looking for a temporary Document Control Specialist to assist with reviewing, routing/ tracking, releasing, and distribution of documents.
Will be responsible for ensuring all documentation revisions are available while identifying and archiving obsolete documents.
The ideal candidate will have the following:
- 2 years of related experience in FDA regulated industry
- Experience with document control software and regulatory requirements- 21 CRF Part 11/ 820 and ISO 13485
- Administration of document management systems
- Strong knowledge of GDP, SOPs, and quality
- High attention to detail
- Strong knowledge of ISO 13485
- Advanced skills with Microsoft Office applications- Word, Excel, Access, and Adobe Acrobat
- Strong written and verbal communication skills
