Tracy Fleming
Documentation Coordinator, R&D at Grifols
- Role
- Documentation Coordinator, R & d at Grifols
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
Experience
Documentation Coordinator, R & d
Apr 2018 — Present · Research Triangle Park, NC, US
Manages the quality document life cycle process to ensure company procedures and regulatory guidelines. Manages Documentum Compliance Manager (DCM), Physical Records Management (PRM) and all other R&D databases. Develops, Implements and improves utilization and management of R&D documents, including document retention polices. Serves as Subject Matter Expert (SME) for DCM and PRM and provides training to R&D staff on system improvements including publication, search queries and discrepancy management. Maintains security of documents and the management system. Oversees transfer of GLP documents and non-regulated study materials to long-term repositories. Interfaces with external auditors and regulatory agencies during audits to retrieve archived documents.
Education
North Carolina State University - College of Management
BA, Business Mangement
1997
North Carolina State University
BA, Business Managment
1997
Skills
- Lims
- CRO
- Clinical Trials
- Gcp
- Biopharmaceuticals
- Regulatory Submissions
- Standard Operating Procedure (Sop)
- Gmp
- Glp
- Capa
- Biotechnology
- 21 Cfr Part 11
- Technology Transfer
- Computer System Validation
- Regulatory Affairs
- Lifesciences
- Clinical Development
- Pharmaceutical Industry
- Sop
- Fda
- Quality Assurance
- Validation
- Quality System
- Change Control
- Software Documentation
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