Position Title: Quality Documentation Control Administrator
Position Summary
The Quality Documentation Control Administrator is responsible for managing and maintaining quality-related documents/quality records within the Quality Management System (QMS). The role of the documentation administrator is to help ensure compliance with regulatory requirements, quality standards, and internal procedures pertaining to documentation control. The individual will collaborate closely with various departments to establish and uphold efficient document control processes.
Responsibilities
* Oversee the creation, review, approval, distribution, and archival of quality-related documents, including policies, procedures, work instructions, forms, and records.
* Maintain document versioning, ensuring that the latest revisions are accessible to relevant personnel and obsolete versions are appropriately archived or disposed of.
* Ensure that all quality-related documents adhere to relevant regulatory requirements, such as FDA regulations, ISO standards, and industry best practices.
* Provide support for the development, implementation, and maintenance of the organization's quality management system (QMS), including document control procedures.
* Assist in coordinating training sessions for employees on document control processes and related quality procedures.
* Prepare and participate in internal and external audits and inspections related to document control processes, ensuring compliance and readiness.
* Support the management and monitoring of KPIs to help identify opportunities for process improvements within the document control system to enhance efficiency, accuracy, and effectiveness.
* Collaborate with stakeholders across various departments, including Quality Assurance, Regulatory Affairs, R&D, Manufacturing, and Supply Chain, to ensure alignment and consistency in document control practices.
* Identify and mitigate risks associated with document control processes to prevent errors, deviations, and non-conformances.
* Able to build strong and positive working relationships with cross-functional teams internationally.
Knowledge and Skills Required
* Bachelor's degree in a relevant field (e.g., Quality Management, Regulatory Affairs, Business Administration) or equivalent experience.
* Strong understanding of document control principles and practices, preferably in a regulated industry.
* Familiarity with regulatory requirements and standards governing document control, such as FDA 21 CFR Part 11, ISO 13485, ISO 9001, or similar.
* Excellent attention to detail and organizational skills, with the ability to manage multiple tasks simultaneously.
* Analytical mindset with problem-solving capabilities and a continuous improvement orientation.
* Ability to work independently with minimal supervision and thrive in a dynamic, fast-paced environment.
* Able to build strong and positive working relationships with cross-functional teams.
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