Position Title : Document Control Resource I
Work Location : Sanford, NC 27330
Assignment Duration : 6 months (possibility of being extended, not to exceed 12 months)
Work Schedule : 8-4 core hours, EST, flexible with prior communication
Work Arrangement : Onsite
Position Summary : The worker will be a team player performing document control tasks, facilitating the lifecycle of master documents, and supporting records management from a closed CA facility.
Key Responsibilities :
- Train and gain access to the Records Management System.
- Collaborate with department stakeholders to index, verify, archive, and possibly transmit, collect / receive applicable site records / documents.
- Note that 'archive' may include boxing / prepping for shipping to off-site storage location.
- Data entry, keyboarding, cross-referencing records in a spreadsheet, and enter into system.
- Facilitate the life cycle of master documents (including but not limited to SOPs, Batch Records, Test Methods, Protocols, Forms, Reports, Specifications, etc.) by functioning as a document workflow coordinator.
- Review, edit, format master documents according to approved procedures and templates, maintain document properties (metadata), monitor document status and approval notifications, distributions and archiving.
- Collaborate with cross-functional departments to secure timely implementation of document change requests and change control associated tasks.
- Issue effective documents including logbooks, procedures, test methods, specifications, batch documentation and labels and maintain issuance logs.
- Execute duties associated with controlled document change requests (i.e., document formatting, approvals, effectiveness, and distribution).
- Assist with and provide ongoing user support for electronic document management system.
- Provide day-to-day operation support for departments (e.g., scheduling, reporting, records, archiving).
- May also support the preparation and assisting as needed, during internal audits and / or regulatory inspections.
- Receive, review and index completed records.
Qualification & Experience :
2 years’ experience working in a regulated industry (preferably GxP).Basic Microsoft Excel functions.Experience in a document control or records management capacity.Minimum education will include AS degree in a Science or Business major (waived if sufficient experience).Ability to stand for up to 4 hours; sit at a computer for 4-8 hours; lift up to 50 lbs (rare).Analytical thinking, self-motivated, keyboarding, attention to detail.Collaboration, team worker, customer-facing with positive communication.Computer skills, Microsoft Suite skills (intermediate Excel, strong MS Word).Time management, ability to speak up, make decisions, positive attitude.