Document Control Associate

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

The Document Control Associate supports document management activities within pharmaceutical and life sciences environments, ensuring compliance with regulatory requirements such as FDA, EMA, and ISO standards. This role is responsible for maintaining accurate documentation, managing document revisions, and ensuring proper control, accessibility, and traceability of quality-related records.

Key Responsibilities:

• Organize and maintain controlled documents, including SOPs, batch records, protocols, and validation reports.
• Ensure compliance with Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) requirements.
• Review documents for accuracy, formatting, completeness, and version control.
• Support document lifecycle activities, including creation, revision, approval, distribution, and archival.
• Maintain document change histories, tracking logs, and audit trails.
• Assist with internal and external audits by retrieving and providing 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.

Preferred Skills:

• Familiarity with electronic document management systems (e.g., Veeva Vault, MasterControl).
• Basic understanding of 21 CFR Part 11 and electronic records requirements.
• Knowledge of data integrity principles, including ALCOA+.
• Basic proficiency in MS Office applications, including Word, Excel, and PowerPoint.

Skills:

• 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.