The Document Specialist reviews and manages archiving activities for regulatory, clinical, and quality documents to ensure accuracy, internal consistency, adherence to company standards, and compliance with regulatory guidances.
The scope of activities includes, but is not limited to the following: maintenance of the QA document control system, assists in managing regulatory files, and interfaces with clinical operations and other functional areas to support their documentation needs. This position requires a high degree of focus and consistent attention to detail.
Essential Duties and Responsibilities
- Process, monitor, and maintain all Quality documents, in hard copy format and electronic systems.
- Creation and implementation of record storage for regulated activities, not limited to production batch records, technical reports, other Quality documentation, e.g. SOPs, protocols, etc.
- Coordinate with multiple departments to compile and archive documents in compliance with regulatory guidance and internal standards, as instructed.
- Verify documents for accuracy against source data. Ensure internal consistency and correct grammar, punctuation, and style.
Education and Experience
- Minimum of Bachelor’s degree in a science-related discipline and 3 years of relevant Quality Assurance or Regulatory document management experience is required, or
- Equivalent combination of education and experience
- Working knowledge of general GxP regulations
- Must be self-motivated and innovative in addressing routine assignments
- Strong organizational skills
- Ability to manage and prioritize multiple projects and activities
- Defined technical computer skills (Microsoft Windows and Office, cloud based file management systems)
- Previous electronic document management system experience preferred
- Strong interpersonal and communication skills