Quality Document Control Specialist

Nephron Pharmaceuticals Corporation; West Columbia (SC); On-site; USD 42,000 - 64,000; Full time

Job summary

Nephron Pharmaceuticals Corporation invites a detail-oriented Document Control professional to join our Quality team in West Columbia, SC. The role focuses on learning and performing document control functions, supporting the Quality Management System, and creating SOPs and change controls in alignment with cGMP and FDA requirements.

Responsibilities include using LabVantage, SharePoint, and DOT Compliance software to prepare and verify batch records, manage archives, and respond to daily

Qualifications

• Technical background with knowledge of cGMP and FDA regulations.
• Strong document control procedures and best practices.
• Competent in Microsoft Word and Excel; adept with PDF workflows.

Responsibilities

• Route and maintain controlled documents including forms, master batch records, SOPs, and methods.
• Maintain archive, LIVE DOCs and distribution lists to reflect latest revisions.
• Assist with batch record preparation and verification per production schedule.
• Respond to emails and DOT Compliance requests; perform audits to ensure correct doc versions.

Skills

Doc control procedures

cGMP knowledge

Word proficiency

Excel proficiency

Adobe Acrobat

Time management

Communication skills

Tools

LabVantage

SharePoint

DOT Compliance software

Job description

Nephron Pharmaceuticals Corporation invites a detail-oriented Document Control professional to join our Quality team in West Columbia, SC. The role focuses on learning and performing document control functions, supporting the Quality Management System, and creating SOPs and change controls in alignment with cGMP and FDA requirements.

Responsibilities include using LabVantage, SharePoint, and DOT Compliance software to prepare and verify batch records, manage archives, and respond to daily