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Associate Document Control CoordinatorThousand Oaks, CA
Day to Day Responsibilities:
- Draft, or Review, also manage EDMQ workflows for Protocols, Studies, Reports, Technical Assessments as needed.
- Building and supporting maintenance of Usability Engineering File by program/ platform
- Support regulatory submissions, design review deliverables, and RTQs
- Build data management system for storage and archival of HF studies
- Data Verify controlled documents
- Responsible for the maintenance of all required documentation for the company.
- Provide services to maintain and control Master Record documents.
- Responsible for word processing and distribution of documents and maintenance of document files in a confidential and secure manner.
- Provide comprehensive administrative services to coordinate and maintain Good Manufacturing Practices (GMP).
- Manage release and control of updates to documents.
- Control distribution of new releases and recall/destruction of obsolete documents.
- Archive documentation organization, data entry, lifting and moving of boxes; must be able to lift up to 50 lbs
- Scanning and loading of documents into the Electronic Document Management System
- Follow step-by-step instructions and perform repetitive functions consistently and accurately
- Act as department representative to communicate and educate clients on DMS processes, answer general questions, troubleshoot problems, and complaint resolution
- Work both independently and in a team environment
- Metrics reporting using Excel tables and charts
- Follow Current Good Manufacturing Practices (cGMP) regulations and Amgen policies and procedures
- Work in a rapidly changing and demanding environment
- Strong attention to detail, including the ability to proofread documents
- Basic understanding of the cGMPs, as related to document requirements
- Controlled document and batch record documentation filing
- Create and maintain interdepartmental training manuals (instructions)
- Additional projects, as assigned;
"This posting is for Contingent Worker, not an FTE"
- Administrative support experience;
- Experience using MS Outlook, Word, Excel, and PowerPoint in an office setting.
- Support department data verification needs.