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Temporary Quality Assurance Specialist (QAS), Document Administration

The Temporary Quality Assurance Specialist (QAS), Document Administration will be responsible for organization and editing of documents to facilitate migration and deployment of the TrackWise Document Management System (DMS) and TrackWise change and exception management modules (QMS). This additionally includes organization and migration, as needed, of legacy documents not migrated to DMS or QMS. This position is located at SOFIE's Center of Excellence in Totowa, NJ but will support document administration needs locally and for the wider SOFIE network.

Essential Duties and Responsibilities

• Under supervision of site QA or corporate document control, prepare migration spreadsheets and perform other word processing and document organization tasks for migration of documents from existing libraries (in SharePoint) to TrackWise.
• Edit documents to be migrated to ensure clean appearance once migrated, and that documents remain clear and readable.
• Edit references and cross references in documents when migrated to ensure those references remain clear and correct.
• Assist in managing document attachments during migration; this may include separating imbedded documents from the body of SOPs, editing attachments, and file and folder organization.
• Under supervision of site QA or corporate document control, organize legacy documents not migrated to TrackWise to ensure that documents remain searchable and readily retrievable.
• To support document control functions generally, as assigned, review documents for completeness, errors, and omissions.
• Perform other word processing duties as assigned.
• Attend quality and operational meetings as necessary. Interface with Corporate QA on document control related issues. Provide work progress updates.
• Other responsibilities as required.

Qualifications

AS Degree in a related field with 2+ years of experience in Quality Assurance or Document Control function (or equivalent combination of education and experience). Understanding of TrackWise products preferred. Knowledge of cGMP regulations preferred. Technical writing skills preferred. Ability to effectively present information and respond to questions from groups of managers and staff. Proficiency in MS Office application required. Strong interpersonal communication skills.