GMP Document Control Specialist

United Consulting Hub, Inc.; United States; On-site; USD 55,000 - 75,000; Full time

Job summary

United Consulting Hub, Inc. is seeking a Document Control Associate to manage GMP/GDP document control in pharmaceutical settings. You will maintain SOPs, batch records, protocols, and validation reports with proper revision and version control to ensure accessibility and traceability.

The role requires EDMS familiarity (Veeva Vault, MasterControl), assist with audits, and coordination with QA, manufacturing, validation, and regulatory teams. Strong MS Office skills are essential.

Qualifications

• Understanding of GMP documentation and document control procedures.
• Strong attention to detail, organizational skills, and accuracy.
• Basic knowledge of EDMS tools such as Veeva Vault and MasterControl is an advantage.
• Basic proficiency in MS Office applications (Word, Excel, PowerPoint).

Responsibilities

• Organize and maintain controlled documents, including SOPs, batch records, protocols, and validation reports.
• Ensure GMP and GDP compliance requirements.
• Review documents for accuracy, formatting, completeness, and version control.
• Support document lifecycle activities: creation, revision, approval, distribution, and archival.
• Maintain document change histories, tracking logs, and audit trails.
• Assist with internal and external audits by retrieving required documentation.
• Coordinate with QA, manufacturing, validation, and regulatory teams to support documentation activities.
• Maintain electronic document management systems (EDMS) and ensure proper document storage and retrieval.

Skills

GMP documentation

Attention to detail

EDMS familiarity

Tools

Veeva Vault

MasterControl

Job description

United Consulting Hub, Inc. is seeking a Document Control Associate to manage GMP/GDP document control in pharmaceutical settings. You will maintain SOPs, batch records, protocols, and validation reports with proper revision and version control to ensure accessibility and traceability.

The role requires EDMS familiarity (Veeva Vault, MasterControl), assist with audits, and coordination with QA, manufacturing, validation, and regulatory teams. Strong MS Office skills are essential.