Aditi Consulting
Document Management Specialist
Aditi Consulting, Thousand Oaks, California, United States, 91362
Payrate:
$35.50 - $37.90/hr.
Responsibilities:
Documentation creation and revision: 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. 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. Change management and workflow: Manage Change Requests: Assist in creating and managing change requests for both training and documentation within relevant systems like Veeva and LMS. Project Management of Workflows: Help manage documentation workflows within Quality Management System (Veeva) to ensure validation and project deadlines are met. Status Reporting: Help assemble regular status updates for OTC E2E Leads and workstreams regarding documentation progress: Data management and system utilization 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. Quality assurance and compliance: Adherence to Standards: Ensure all revised documentation adheres to relevant GxP regulations and internal company standards. Accuracy and Completeness: Verify the accuracy, completeness, and clarity of the information presented in the revised documents. 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.
Top 3 Must Have Skill Sets:
Must have experience managing documents in Veeva Experience managing Order To Cash (OTC) processes Experience managing GxP document revision Experience with project management
Pay Transparency:
The typical base pay for this role across the U.S. is:
$35.50- $37.90/hr.
Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (https://www.aditiconsulting.com/privacypolicy).
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human based decision making in employment decisions. By applying to this position, you agree to Aditi's use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting #
25-21500
$35.50 - $37.90/hr.
Responsibilities:
Documentation creation and revision: 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. 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. Change management and workflow: Manage Change Requests: Assist in creating and managing change requests for both training and documentation within relevant systems like Veeva and LMS. Project Management of Workflows: Help manage documentation workflows within Quality Management System (Veeva) to ensure validation and project deadlines are met. Status Reporting: Help assemble regular status updates for OTC E2E Leads and workstreams regarding documentation progress: Data management and system utilization 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. Quality assurance and compliance: Adherence to Standards: Ensure all revised documentation adheres to relevant GxP regulations and internal company standards. Accuracy and Completeness: Verify the accuracy, completeness, and clarity of the information presented in the revised documents. 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.
Top 3 Must Have Skill Sets:
Must have experience managing documents in Veeva Experience managing Order To Cash (OTC) processes Experience managing GxP document revision Experience with project management
Pay Transparency:
The typical base pay for this role across the U.S. is:
$35.50- $37.90/hr.
Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (https://www.aditiconsulting.com/privacypolicy).
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human based decision making in employment decisions. By applying to this position, you agree to Aditi's use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting #
25-21500