Dale Workforce Solutions
Document Management Specialist
Dale Workforce Solutions, Thousand Oaks, California, United States, 91362
Client: biotech
Location: Remote (EST 8-5pm)
Duration: 1 year + extensions
This role is assisting moving docs to SAP4 (existing project/ existing process) they will just be supporting
1.Documentation creation and revision a.GxP Documentation: Working with Business Process leads, create and revise GxP documentation, such as Standard Operating Procedures (SOPs), Work Instructions (WIs), Business Process Documents (BPDs), and Forms to align with the new SAP S/4HANA processes and ensure compliance with validation timelines. b.Non-GxP Documentation: Create and revise work instructions and other relevant non-GxP documentation as needed to support the updated processes resulting from the transition.
2.Change management and workflow a.Manage Change Requests: Assist in creating and managing change requests for both training and documentation within relevant systems like Veeva and LMS. b.Project Management of Workflows: Help manage documentation workflows within Quality Management System (Veeva) to ensure validation and project deadlines are met.
3.Status Reporting: Help assemble regular status updates for OTC E2E Leads and workstreams regarding documentation progress. a.Data management and system utilization b.Smartsheet tracking: Utilize Smartsheet dashboards to coordinate tracking of document progress, including linking parent/child relationships, updating comments, changing statuses, and ensuring data accuracy within the dashboard.
4.Quality assurance and compliance a.Adherence to Standards: Ensure all revised documentation adheres to relevant GxP regulations and internal company standards. b.Accuracy and Completeness: Verify the accuracy, completeness, and clarity of the information presented in the revised documents. c.Review and Editing: Participate in the review and editing process to ensure documents are clear, concise, and effectively convey the intended information.
Requirements include: Experience in developing regulated or process documents with the ability to deliver high quality documentation including technical writing. Sound project management and organizational skills. Ability to work independently and as a team player, demonstrating excellent collaboration and people management skills, preferably to include experience in influencing and negotiation. Experience in leading virtual teams within different regions and cultures. Proficient in discerning, high quality verbal and written communication. Experience of electronic clinical trial/SOP/document systems (e.g., Veeva).Good working knowledge of Microsoft Word. Experience preferably in R&D/pharmaceutical industry, with knowledge of quality and compliance.
This role is assisting moving docs to SAP4 (existing project/ existing process) they will just be supporting
1.Documentation creation and revision a.GxP Documentation: Working with Business Process leads, create and revise GxP documentation, such as Standard Operating Procedures (SOPs), Work Instructions (WIs), Business Process Documents (BPDs), and Forms to align with the new SAP S/4HANA processes and ensure compliance with validation timelines. b.Non-GxP Documentation: Create and revise work instructions and other relevant non-GxP documentation as needed to support the updated processes resulting from the transition.
2.Change management and workflow a.Manage Change Requests: Assist in creating and managing change requests for both training and documentation within relevant systems like Veeva and LMS. b.Project Management of Workflows: Help manage documentation workflows within Quality Management System (Veeva) to ensure validation and project deadlines are met.
3.Status Reporting: Help assemble regular status updates for OTC E2E Leads and workstreams regarding documentation progress. a.Data management and system utilization b.Smartsheet tracking: Utilize Smartsheet dashboards to coordinate tracking of document progress, including linking parent/child relationships, updating comments, changing statuses, and ensuring data accuracy within the dashboard.
4.Quality assurance and compliance a.Adherence to Standards: Ensure all revised documentation adheres to relevant GxP regulations and internal company standards. b.Accuracy and Completeness: Verify the accuracy, completeness, and clarity of the information presented in the revised documents. c.Review and Editing: Participate in the review and editing process to ensure documents are clear, concise, and effectively convey the intended information.
Requirements include: Experience in developing regulated or process documents with the ability to deliver high quality documentation including technical writing. Sound project management and organizational skills. Ability to work independently and as a team player, demonstrating excellent collaboration and people management skills, preferably to include experience in influencing and negotiation. Experience in leading virtual teams within different regions and cultures. Proficient in discerning, high quality verbal and written communication. Experience of electronic clinical trial/SOP/document systems (e.g., Veeva).Good working knowledge of Microsoft Word. Experience preferably in R&D/pharmaceutical industry, with knowledge of quality and compliance.