Document Control & Compliance Specialist

Nephron Pharmaceuticals Corporation; Columbia, Northern (SC, KY); Hybrid; USD 42,000 - 64,000; Full time

Job summary

Nephron Pharmaceuticals Corporation seeks a Document Control Specialist to learn and perform document control functions, support the Quality Management System, and create and maintain SOPs and change controls in accordance with cGMP.

You will use LabVantage, SharePoint, and DOT Compliance software, prepare batch records, maintain archives, and manage document distribution while coordinating with cross‑functional teams. Some overtime and weekend work may be required.

Qualifications

• Minimum of 1 year in the pharmaceutical industry preferred.
• 1–3 years of experience with Microsoft Word, Excel, and PowerPoint preferred.
• Knowledge of cGMP and FDA regulations.
• Proficient in Microsoft Word and Excel; Adobe Acrobat advanced features.

Responsibilities

• Route new and revised controlled documents using DOT Compliance software systems.
• Assist with document accuracy including formatting headers/footers, spelling, grammar, and numbering.
• Manage and maintain document archive process.
• Maintain original and working copy binders with latest revisions.
• Maintain LIVE DOCs with current revisions.
• Update Master Distribution List and Table of Contents with current document data.
• Perform daily and quarterly audits to ensure correct document versions are used.
• Assist with batch record preparation: review schedule, generate batch records, create batch IDs, respond to requests.

Skills

cGMP

FDA regulations

Document control

Microsoft Word

Microsoft Excel

Adobe Acrobat

Time management

Communication skills

Cross-functional collaboration

Education

1 year in pharmaceutical industry

Tools

LabVantage

SharePoint

DOT Compliance software

Job description

Nephron Pharmaceuticals Corporation seeks a Document Control Specialist to learn and perform document control functions, support the Quality Management System, and create and maintain SOPs and change controls in accordance with cGMP.

You will use LabVantage, SharePoint, and DOT Compliance software, prepare batch records, maintain archives, and manage document distribution while coordinating with cross‑functional teams. Some overtime and weekend work may be required.