Job Title: Document Controller
Location: Mansfield, MA
Shift: Mon. – Fri. (9a-5p)
Responsible for supporting the maintenance of the document control system
Responsible for formatting, proper spelling and clarity of text for any written documents submitted to document control
Review all electronic documents submitted to document control for correct formatting, spelling and clarity of text before releasing as approved documents
Maintains all ISO/FDA standard operating procedures, work instructions and forms
Maintains revision and approval status of all documents
Maintains official copies (either hard copy or electronic) 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, validation records, batch records and notebooks.
Responsible for supporting record retention activities (collection, shipment and retrieval to/from offsite storage)
Minimum of 1-2 years’ experience in document management using electronic document management systems
Preferred experience with Agile and /or Adaptiv PLM systems
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.
Solid organizational and document management skills