Associate Document Control Coordinator

Location: Thousand Oaks, CA
Date Posted: 11-08-2018
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
Summary:
  •  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.
Responsibilities include:
  • 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;
Skills:
  • Administrative support experience;
  • Experience using MS Outlook, Word, Excel, and PowerPoint in an office setting.
  • Support department data verification needs.
"This posting is for Contingent Worker, not an FTE"
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