Job Summary:

The Quality Documentation Administrator is responsible for maintaining, organizing, and managing all quality-related documents and records within the organization. This role ensures that all documentation is up-to-date, accessible, and compliant with industry standards and regulations. The Quality Documentation Administrator works closely with the Quality Assurance (QA) team, production staff, and other departments to support quality management initiatives and continuous improvement efforts.

Key Responsibilities:

• Document Management:

  • Develop and maintain a document control system to manage all quality documents, including standard operating procedures (SOPs), work instructions, quality manuals, and records.
  • Ensure that all documents are properly categorized, indexed, and stored for easy retrieval and access.
  • Regularly review and update documents to reflect current practices, standards, and regulations.

• Compliance and Standards:

  • Ensure all quality documentation complies with relevant industry standards, regulations, and company policies.
  • Assist in the preparation and maintenance of documentation required for regulatory inspections and audits.
  • Stay updated on changes in regulations and standards to ensure continuous compliance.

• Quality Assurance Support:

  • Collaborate with the QA team to develop and implement quality assurance processes and procedures.
  • Assist in the preparation of quality reports, presentations, and documentation for internal and external stakeholders.
  • Participate in internal audits and support external audits by providing necessary documentation and records.

• Training and Communication:

  • Conduct training sessions for employees on quality documentation procedures and requirements.
  • Communicate changes in documentation and quality standards to relevant staff members.
  • Serve as the point of contact for document control-related inquiries and issues.

• Continuous Improvement:

  • Identify opportunities for process improvement in document management and quality assurance practices.
  • Implement best practices for document control and quality documentation.
  • Support quality improvement projects and initiatives as needed.

Qualifications:

• Education:

  • Bachelor's degree in Quality Management, Business Administration, or a related field preferred.
  • Relevant certifications (e.g., ISO 9001 Lead Auditor, Six Sigma) are a plus.

• Experience:

  • Minimum of 2 years of experience in document control, quality assurance, or a related role.
  • Experience in a regulated industry (e.g., medical manufacturing, pharmaceuticals) is preferred.

• Skills and Competencies:

  • Strong organizational and time management skills.
  • Excellent attention to detail and accuracy.
  • Proficient in using document management systems and software.
  • Knowledge of quality management systems (QMS) and regulatory requirements.
  • Strong communication and interpersonal skills.
  • Ability to work independently and collaboratively in a team environment.

Working Conditions:

• Office-based role with occasional visits to production or operational areas.
• May require occasional travel for training or audit purposes.

Reporting Line:

• Reports to the Quality Assurance Manager.