We are seeking a Quality Assurance Document Specialist to join our team and support our quality systems processes by maintaining and processing all documentation produced through the clinical manufacturing process. As a Document Specialist, you have excellent oral and technical writing skills. You are highly organized. You demonstrate high ethical standards, trustworthiness, and leadership skill. You have the ability to function under deadline and provide high quality deliverables. This position is based at our Fargo, ND location.
About the Role:
As a Quality Assurance Document Specialist, you will be responsible for maintaining quality assurance standards, processes and controls, and to positively model and represent those standards, processes and controls to all employees with emphasis on compliance with the corporate quality manual, compliance with internal SOPs, continual process improvement, demonstration of good documentation practices. Tasks will include documenting incoming documents on applicable spreadsheets, scanning and e-filing, organizing and filing hardcopies, archival, and proofreading documents.
- At least one year of document control experience within a field subject to regulatory compliance (preferred)
- Excellent oral and technical writing skills with the ability to interface effectively and professionally at all levels
- Familiarity with Content Management Systems, preferably AssurX, NetSuite, and SharePoint
- Proficient with Microsoft Office Suite, including advanced Excel functions (e.g., pivot tables)
- Ability to work on cross functional teams
- Highly organized