Overview
Document Control Associate Jobs in United States at United Consulting Hub
Title: Document Control Associate
Company: United Consulting Hub
Location: United States
Job Title: Document Control Associate
Type: Contract
Location: Remote
Experience: 0–2 Years
Job Summary:
We are looking for a detail-oriented Document Control Associate to manage controlled documents and ensure compliance with GMP, GDP, and regulatory requirements within the quality management system.
Key Responsibilities:
- Maintain, organize, and control quality documents, including Standard Operating Procedures (SOPs), batch records, protocols, reports, and related documentation.
- Ensure documentation complies with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Review documents for formatting, accuracy, completeness, and version control before approval and release.
- Manage the complete document lifecycle, including creation, revision, review, approval, distribution, archival, and retrieval.
- Track document revisions and maintain accurate audit trails within the Electronic Document Management System (EDMS).
- Support internal and external audits by providing required documentation and ensuring document readiness.
- Collaborate with Quality Assurance, Manufacturing, Regulatory Affairs, and cross-functional teams to maintain documentation compliance.
- Maintain and update electronic document management systems (EDMS) while ensuring data integrity and confidentiality.
- Assist in implementing document control processes and continuous improvement initiatives.
Required Skills:
- 0–2 years of relevant experience.
- Basic knowledge of GMP, GDP, and document control practices.
- Familiarity with EDMS tools (Veeva, MasterControl) is a plus.
- Knowledge of 21 CFR Part 11 and ALCOA+ is preferred.
- Proficiency in MS Office (Word, Excel, PowerPoint).
- Strong attention to detail and organizational skills.