Document Control Specialist for QA & Regulatory Audits

Express Employment Professionals - Cincinnati East; California (MO); On-site; USD 55,000 - 75,000; Full time

Job summary

Express Employment Professionals - Cincinnati East seeks a Document Control Administrative Assistant to ensure accuracy, completeness, and regulatory compliance of controlled documents. You will manage SOPs, batch records, and reports, coordinating with quality teams and regulatory affairs.

The role requires at least 3 years in document control or QA within a regulated environment, strong organizational skills, and proficiency with EDMS.

Qualifications

• Minimum 3 years of industry experience in document control quality assurance or regulatory affairs.
• Strong understanding of document control principles and regulatory requirements (FDA, GMP).
• Experience with EDMS and document management software.

Responsibilities

• Manage the document control process, including creating, revising, reviewing, approving, and archiving SOPs, batch records, protocols, and reports.
• Ensure all quality documents are accurate, compliant with regulatory requirements and internal standards.
• Monitor and track document change requests with proper routing and approval.
• Collaborate with subject matter experts, quality teams, and regulatory affairs to reflect current processes.
• Perform audits of the document control system to identify gaps and improvements.
• Train employees on document control procedures and processes.
• Prepare documentation for internal and external audits and regulatory inspections.
• Maintain secure, organized document repository both electronic and hard copy.
• Stay updated on industry trends, regulations, and guidelines related to document control and QA.

Skills

Attention to detail

Organizational skills

Cross-functional collaboration

Documentation management

Process improvement

Tools

EDMS

Job description

Express Employment Professionals - Cincinnati East seeks a Document Control Administrative Assistant to ensure accuracy, completeness, and regulatory compliance of controlled documents. You will manage SOPs, batch records, and reports, coordinating with quality teams and regulatory affairs.

The role requires at least 3 years in document control or QA within a regulated environment, strong organizational skills, and proficiency with EDMS.