Company Summary:
One of the top bio-pharmaceutical companies in the world is looking for a Documentation Specialist II to join their Quality team on a 6-month contract. This company leads the development and research for some of the most important drug treatments for life-threatening diseases including HIV and Hepatitis.
The Documentation Specialist II will be responsible for:
- Utilising VeevaVault to organize paper and electronic records
- Consistently applies Good Documentation Practices (GDP) in received paper records
- Scans paper records, verifies completeness of electronic copies, and uploads electronic copies into Electronic Document Management System (EDMS), e.g., true copy certification process.
- Supports periodic audit of archived paper records.
- Works on assignments that are moderately complex in nature where ability to recognize deviation from accepted practice is required.
- Identifies deviations from document control procedures. Notifies IT management and assists with issue resolution.
- Provides support for internal and regulatory audits/inspections as required.
The Documentation Specialist II should have the following qualifications:
- 3+ years of relevant experience in a regulated industry. Direct experience with documentation management in a GxP pharmaceutical setting is preferred, including extensive experience with GDP.
- Demonstrates strong working knowledge of, and has extensive relevant experience with, managing paper records, including true electronic copy creation, archiving originals in off-site storage, and use of a records management system, such as FileTrail or similar (in a GxP environment is preferred).
- Demonstrates strong verbal, technical writing, and interpersonal skills.
- Demonstrates strong working knowledge of Document Control fundamentals, Quality Systems, and GxP requirements.
- Demonstrates strong working knowledge of Electronic Document Management Systems (EDMS), such as VeevaVault Quality Docs or similar (in a GxP environment is preferred), including relevant experience with managing and troubleshooting review/approval/obsoletion/retirement workflows and document classification/metadata.
- Demonstrates effective organizational, planning, and time management skills.
- Demonstrates high attention to detail, while service-oriented, with the ability to process high volumes of requests/paper record submissions and archival in a timely, prioritized and compliant manner.
- Demonstrates strong computer skills with software used in document processing, which includes MS Excel, Word, Adobe Acrobat.
Benefits:
- Healthcare coverage
- Competitive Pay Rate
- 401k
If you are interested in the Documentation Specialist II role, then please don't wait to apply.
