Interaction with multiple staff members to define requirements within GMP documents.
Writing, formatting and processing documents in approved document management system May lead meetings with cross-functional team members to determine path forward for document creation.
Track and provide regular updates, status reports or projected timelines for assigned tasked to key Points of Contact
Development and facilitation of the creation and/or revision of materials such as SOPs, manuals, and related business process documentation in conjunction with Subject Matter Experts.
Candidate must conduct these activities with the ability to deliver high quality documentation including technical writing in accordance with agreed timelines and in adherence with format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality.
Develops, writes, edits, and formats materials such as Quality Requirement Documents, Standard Operating Procedures, Business Practices, forms, checklists, technical manuals, installation guides, user manuals, and related technical and business process documentation.
When creating, updating and enhancing the documentation, adhere to format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality.
Additionally, this position will be required to administer the processing of documents via the established document management system and electronic document repository.
May require communication through a variety of media (e.g., CD, intranet, on-line training, etc.);
Experience in quality and compliance documentation