CGMP Document Control Specialist

RXinsider LTD.; Columbia, Northern (SC, KY); Hybrid; USD 45,000 - 65,000; Full time

Job summary

RXinsider LTD. in Columbia, SC seeks a Document Control Specialist to learn and perform document control functions, support the Quality Management System, and create/maintain SOPs and change control records in a cGMP environment.

Experience with LabVantage, SharePoint and DOT Compliance software is preferred. Responsibilities include routing documents, maintaining archives, updating distribution lists, and assisting with batch records using LabVantage.

Qualifications

• Knowledge of cGMP and FDA regulations in a pharma setting.
• Proficiency with Word, Excel and PDF workflows.
• Experience with document control procedures and SOPs.
• Familiar with LabVantage and DOT Compliance tools.
• Strong time management and cross‑functional communication.

Responsibilities

• Route new and revised controlled documents using DOT Compliance systems.
• Ensure document formatting accuracy (headers/footers, grammar, numbering).
• Maintain document archive and live documents with latest revisions.
• Update Master Distribution List and Table of Contents with current details.
• Perform daily/quarterly audits of document versions used for batch records.
• Assist with batch record generation and LabVantage ID creation.
• Respond to emails and DOT system activities promptly.

Skills

cGMP knowledge

FDA regulations

Document control

Microsoft Word

Microsoft Excel

Adobe Acrobat

SharePoint

LabVantage

Time management

Communication

Tools

LabVantage

DOT Compliance software

SharePoint

Job description

RXinsider LTD. in Columbia, SC seeks a Document Control Specialist to learn and perform document control functions, support the Quality Management System, and create/maintain SOPs and change control records in a cGMP environment.

Experience with LabVantage, SharePoint and DOT Compliance software is preferred. Responsibilities include routing documents, maintaining archives, updating distribution lists, and assisting with batch records using LabVantage.