Our organization is seeking a documentation specialist to join the team.
About the Role:
1. Coordinate and execute internal and external operations review and approval of manufacturing related documentation.
2. Progress documents through all stages to achieve schedule timelines and comply with site policies & cGMPs.
3. A key member on the operations readiness team during NPI, TT and routine Manufacturing, interfacing with stakeholders to ensure manufacturing documents are prepared, executed and post-approved.
4. Perform duties in accordance with GMP requirements, SOPs and controlled documents.
5. Assist in preparing progress reports/presentations as required.
6. Revise, update and format documentation including MBRs, SOPs, forms, logbooks and label templates.
7. Write/review manufacturing documentation (SOPs, Manufacturing Records & Logbooks) ensuring it is current, accurate and compliant with regulatory requirements.
8. Exercise judgment within defined procedures and practices to determine appropriate action.
9. Lead or participate IIA, RCI sessions.
10. Responsible for inventory maintenance and MBR pre and post-execution review and approval tracking.
11. Manage the Manufacturing Finite Schedule, including facilitating meetings, tracking adherence to schedule and KPI monitoring and reporting.