Tracy Taylor
Lead Document Control Administrator @ Thermo Fisher Scientific
About
eDMS Site Administrator & Qualified Subject Matter Expert (QSME) Trainer Role Overview: Provide direct support to the Sr. Production Manager. Perform technical writing and manage Documentum workflows. Utilize SAP for purchasing and batch verification. Key Responsibilities: eDMS Administration: Oversee the electronic Document Management System (eDMS) to ensure efficient document control and compliance with regulatory standards. QSME Training: Act as a Qualified Subject Matter Expert (QSME) Trainer, delivering comprehensive training sessions to ensure team proficiency in eDMS and related processes. Technical Writing: Develop and maintain technical documentation, ensuring clarity, accuracy, and compliance with industry standards. Documentum Workflows: Manage and optimize Documentum workflows to streamline document approval and distribution processes. SAP Utilization: Leverage SAP for purchasing activities, ensuring accurate and timely procurement of materials. Perform batch verification to maintain data integrity and operational efficiency. Support to Sr. Production Manager: Provide direct support to the Sr. Production Manager, assisting with various tasks to enhance production operations and achieve organizational goals. Skills and Qualifications: Expertise in eDMS administration and Documentum workflows. Proficient in SAP for purchasing and batch verification. Strong technical writing skills with attention to detail. Experienced in delivering QSME training sessions. Excellent organizational and communication skills. Ability to work collaboratively with cross-functional teams.
United States
Greater Florence
Pharmaceuticals
Document Control Lead, Manufacturing Operations, Document Formatting, Quality System Training, Trackwise Administrator, eDMS Administrator, Document Control, Document Drafting, Document Review, Technical Documentation, Editing, Documentum, Electronic Document Management System (EDMS), GMP, Pharmaceutical Industry, FDA, Manufacturing, Document Management, SAP, Process Improvement
Experience

Quality Assurance Documentation Administrator II
Florence, South Carolina
eSkills: Manufacturing Operations: Proficient in overseeing and optimizing manufacturing processes to ensure efficiency, quality, and compliance with industry standards. Quality System Training: Experienced in developing and delivering comprehensive training programs on quality systems to ensure team adherence to regulatory requirements and best practices. Trackwise Administrator: Skilled in administering Trackwise, managing workflows, and ensuring effective issue tracking and resolution. eDMS Administrator: Expertise in managing electronic Document Management Systems (eDMS), ensuring seamless document control and regulatory compliance. Document Formatting: Proficient in formatting technical documents to ensure clarity, consistency, and professional presentation. Electronic Document Management System (EDMS): Extensive experience in utilizing EDMS for efficient document storage, retrieval, and management. Document Management: Strong capabilities in organizing, storing, and maintaining documents to ensure easy access and compliance with regulatory standards. Document Control: Expertise in implementing and maintaining document control processes to ensure accuracy, consistency, and compliance. Documentum: Skilled in using Documentum for managing document workflows, approvals, and distribution. Quality System: In-depth knowledge of quality systems and their implementation to ensure product and process compliance with regulatory standards. Document Review: Proficient in reviewing technical documents for accuracy, completeness, and compliance with industry standards. Technical Documentation: Strong technical writing skills, capable of creating clear, concise, and comprehensive technical documentation.

Documentation Specialist
United States
Documentum Control: Expertly manage Documentum workflows to ensure efficient document approval, distribution, and compliance with regulatory standards. Batch Record Administrator for the Site: Oversee the administration of batch records, ensuring accuracy, completeness, and compliance with Good Manufacturing Practices (GMP). Records Retention: Implement and maintain records retention policies to ensure proper storage, retrieval, and disposal of documents in compliance with regulatory requirements. Condor Administrator for the Site: Administer Condor systems, ensuring efficient operation and compliance with site-specific requirements and industry standards. SharePoint Administration for the Document Control Department: Manage SharePoint for the Document Control department, ensuring efficient document storage, retrieval, and collaboration. GMP SharePoint Liaison for the Site: Act as the liaison for GMP SharePoint, facilitating communication and collaboration between departments to ensure compliance with GMP standards. Level 1 SHE Team Member: Participate as a Level 1 Safety, Health, and Environment (SHE) team member, contributing to the development and implementation of safety protocols and ensuring a safe working environment.

Administrative Associate
United States
Assistant to Sr. Production Manager: Provide comprehensive support to the Sr. Production Manager, assisting in the coordination and execution of production activities to ensure operational efficiency and effectiveness. Support for a Department of Over 50 Employees: Deliver administrative and operational assistance to a large department, ensuring smooth workflow and addressing the needs of over 50 employees. Facilitation of Daily Operations Meetings: Organize and facilitate daily operations meetings, ensuring effective communication, coordination, and decision-making among team members to drive productivity and resolve issues promptly.

Business Support Specialist
United States
Performed Monthly Inspections and Data Compilation for OSHA-Regulated Equipment: Conduct thorough monthly inspections of OSHA-regulated equipment, ensuring compliance with safety standards and regulations. Compile and analyze inspection data to identify trends and areas for improvement. Administrative Support to the EH&S Team: Provide comprehensive administrative support to the Environmental Health & Safety (EH&S) team, assisting with documentation, reporting, and coordination of safety initiatives. Direct Support to Safety and Environmental Managers: Offer direct support to Safety and Environmental Managers, aiding in the development and implementation of safety protocols, environmental policies, and compliance strategies.
Education
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