Title: Document Controller
Location: Lebanon, IN
Duration: 18 month contract (potential of extension)
Overview
We’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 QualityDocs).
• Ensure documents meet GMP/GxP and company compliance standards; 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.
Qualifications
• Experience in document control within pharma/biotech/medical device or other regulated
industries.
• Hands‑on use of an EDMS (ideally Veeva QualityDocs; MasterControl, Documentum,
TrackWise, etc. also relevant).
• Solid understanding of GMP/GxP and documentation compliance best practices.
• Strong attention to detail, organization, and follow‑through; comfortable managing high
document volumes.
• Effective communication skills and ability to collaborate with SMEs and cross‑functional
teams.
Preferred Experience
• 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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