Job Description

BRIEF DESCRIPTION

The Documentation Specialist/Administrator in Quality is responsible for managing, maintaining, and improving the organization’s quality documentation system. This role ensures compliance with internal standards, industry regulations, and customer requirements by overseeing document control processes, supporting audits, and facilitating continuous improvement initiatives.

The ideal candidate is detail-oriented, organized, and collaborative, with a strong understanding of quality management systems (QMS) and documentation best practices.

Responsibilities

• Document Control & Management
• Maintain and update quality manuals, procedures, work instructions, and records.
• Ensure proper version control, approvals, and distribution of documents.
• Archive obsolete documents in accordance with retention policies.

Compliance & Standards

• Support compliance with ISO or other applicable regulatory requirements.
• Ensure documentation aligns with corporate quality policies and industry standards.
• Assist in preparing documentation for internal and external audits.

Process Improvement

• Identify opportunities to streamline documentation processes.
• Collaborate with cross-functional teams to improve clarity, accessibility, and usability of documents.
• Implement digital tools or systems to enhance document management efficiency.

Training & Support

• Provide guidance to staff on documentation procedures and requirements.
• Train employees on document control systems and best practices.
• Act as a resource for quality-related documentation inquiries.

Qualifications

Education: Bachelor’s degree in Quality Management, Business Administration, or related field (or equivalent experience).

Experience

• 2+ years in documentation control, quality assurance, or administrative support.
• Familiarity with ISO 9001, GMP, or other quality standards.

Skills

• Strong organizational and attention-to-detail skills.
• Proficiency with document management systems (e.g., SharePoint, MasterControl, Bluebeam or similar).
• Excellent written and verbal communication.
• Ability to work independently and collaboratively across departments.