Document Control Admin Assistant Needed... Call or Text 661.775.2570

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

DOCUMENT CONTROL ADMINISTRATIVE ASSISTANT

As a Document Control Specialist, you will play a critical role in ensuring the accuracy, completeness, and compliance of all documentation. You will collaborate with cross-functional teams to maintain a robust document control system, supporting the company's commitment to producing high-quality products.

Responsibilities

• Manage the document control process, including creating, revising, reviewing, approving, and archiving quality-related documents such as Standard Operating Procedures (SOPs), batch records, protocols, and reports.
• Ensure that all quality-related documents are consistent, accurate, and compliant with regulatory requirements and internal standards.
• Monitor and track document change requests, ensuring proper routing, approval, and implementation according to established procedures.
• Collaborate with subject matter experts, quality teams, and regulatory affairs to ensure that documents accurately reflect current processes and requirements.
• Perform regular audits of the document control system to identify gaps, inconsistencies, or areas for improvement.
• Train employees on document control procedures and processes to ensure understanding and adherence.
• Assist in the preparation of documentation for internal and external audits, as well as regulatory inspections.
• Maintain a secure and organized document repository, both electronically and in hard copy format, ensuring efficient retrieval and storage of documents.
• Stay updated on industry trends, regulations, and guidelines related to document control and quality assurance.
• Additional duties as assigned.

Minimum Qualifications

Knowledge

• Minimum of 3 years of industry experience required.
• Strong understanding of document control principles, quality assurance practices, and regulatory requirements (e.g., FDA, GMP).
• Prior experience in document control, quality assurance, or regulatory affairs within a pharmaceutical or similar regulated industry

Skills/ Abilities

• Excellent attention to detail and strong organizational skills.
• Proficiency with document management systems and software.
• Effective communication skills, both written and verbal.
• Ability to collaborate with cross-functional teams and manage multiple tasks simultaneously.
• Strong problem-solving skills and a proactive attitude toward process improvement.
• Familiarity with electronic document management systems (EDMS) is a plus.
• Planning & organizing
• Team player attitude that is a highly disciplined, problem-solver with a strong work ethic.
• Flexibility/ adaptability/ multi-tasking

Qualified applicants with arrest or conviction records will be considered for employment following the law. Including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.