Document Controller
Job in
Lebanon, Boone County, Indiana, 46052, USA
Listed on 2026-01-24
Listing for:
Medasource
Contract
position Listed on 2026-01-24
Job specializations:
-
Quality Assurance - QA/QC
-
Administrative/Clerical
Job Description & How to Apply Below
Duration: 18 month contract (potential of extension)
OverviewWe’re seeking a detail‑oriented Document Controller to support controlled documentation across a highly regulated pharmaceutical environment. You’ll manage the full document lifecycle—creation, review/approval routing, version control, and archiving—within our electronic document management system (EDMS), ensuring compliance with internal standards and regulatory requirements.
Key Responsibilities- Manage, organize, and maintain controlled documents (SOPs, protocols, work instructions, forms) within the EDMS (Veeva Quality Docs).
- Ensure documents meet GMP/GxP and company compliance; maintain audit‑ready records.
- Execute document revisions, updates and version control; track changes and effective dates.
- Coordinate cross‑functional reviews and approvals (QA, Manufacturing, Engineering, R&D, Labs).
- Monitor document status and proactively follow up to keep workflows on schedule.
- Support document archiving, periodic reviews, and retention requirements.
- Partner with internal stakeholders and contractors to standardize formats and improve documentation processes.
- Experience in document control within pharma/biotech/medical device or other regulated.
- Hands‑on use of an EDMS (ideally Veeva Quality Docs; Master Control, Documentum, Track Wise, etc. also relevant).
- Solid understanding of GMP/GxP and documentation compliance best practices.
- Strong attention to detail, organization, and follow‑through; comfortable managing high.
- Effective communication skills and ability to collaborate with SMEs and cross‑functional teams.
- Prior coordination of review/approval workflows and change control.
- Familiarity with quality systems and audit support.
- Experience supporting documentation for manufacturing, utilities, or laboratory operations.
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