Document Management System Administrator
Dart NeuroScience LLC (DNS) is a privately held Delaware Limited Liability Company with offices in San Diego CA. DNS will discover new technologies and develop new therapies to help maintain cognitive vitality throughout life.
The Document Management System Administrator is responsible for administration of the electronic document management system (EDMS), internal and off-site document archival, assisting individual users with implementation and effective use of the EDMS for document lifecycle management, and oversight of GXP SOP system.
Essential Duties and Responsibilities
Electronic Data Management System
- Maintain change control of electronic document management system
- Set up new EDMS user accounts and assign EDMS roles and authorizations
- Instruct corporate-wide EDMS user training
- Interface with key department personnel to assist with general GxP document management and setting up workflows
- Maintain Technical Area and Quality Records according to company record retention policy (internal filing and off-site archival).
- Participate in quality system audits as the functional area representative.
- Serve as company liaison with EDMS and software vendors
Standard Operating Procedures (SOPs) Control
- Perform duties in compliance with applicable FDA and state regulations and standards.
- Oversee GXP Standard Operating Procedure change requests, release, distribution and periodic review processes
- Assign document numbers and maintain document trackers and SOP change request history logs
- Expedite requests and troubleshoot issues with document requests
- Other duties as assigned
- Familiarity with GXP documentation 21 CFR Part 11 Electronic Records; Electronic Signatures, and software validation preferred.
- Experience with management and change control of electronic document management systems (Experience with Qumas DocCompliance a plus)
- Experience in a regulated environment
- A minimum of 3 to 5 years document management or related experience within the pharmaceutical or biotechnology industry
- Bachelor’s degree or equivalent combination of education and experience
- Prior experience in Quality Assurance, Clinical, Data Management, or Regulatory Affairs a plus
DNS offers competitive salaries and a great benefits package including paid holidays, incentive bonuses, healthcare, vision, dental, long-term disability, life insurance, flexible spending and a 401(k) retirement savings plan.
- Ability to speak effectively before groups of employees and management of organization.
- Strong written, verbal, analytical, and interpersonal skills
- Self-motivated; Team player; Ability to multitask; Time management and organizational skills
- Strong computer skills including proficiency using Windows OS, MS Office (Excel, Word, Outlook, PowerPoint, etc.), reporting applications such as Crystal Reports or Business Objects; familiarity with Microsoft SharePoint a plus.
For more information please visit our web site at www.dartneuroscience.com .
Dart NeuroScience LLC - 12 months ago