Administration, support, and configuration of computer applications including quality, regulatory, and/or document management systems.
Member of global application support team for an Amplexor based life sciences suite that provides Regulatory (RIM/Publishing), Quality (QMS) and Document (DMS/CMS) management functionality.
Support responsibilities include account administration, end-user assistance, escalation to vendor when needed
Configuration responsibilities include overall system configuration as well as work-flow enhancements
Evaluating enhancement requests to ensure global requirements are maintained
Design software or business process solutions to solve potentially complex business problems
Develop and update system support documents and procedures
Collaborate and provide assistance to other team members
Define functional requirements, create design specifications, and write/execute validation documents for application enhancements.
Update training documents and procedures as needed
Participates in major/minor system upgrades and implementation.
Provide system monitoring and maintenance to ensure system performance and efficiency to allow 24x7 operation.
All other duties as assigned.
Bachelor of Science or Arts degree, preferably in Computer Science or MIS with 0-2 years of experience; or a minimum of 1 years relevant Business or IT experience
1-3 years experience supporting or administering a document management, quality management, and or regulatory management system or suite such as Documentum, Veeva Vault, Trackwise or Amplexor is preferred.
1-3 years working in an FDA regulated environment is preferred.
Experience in project management preferred, preferably managing computer application development projects.
Excellent troubleshooting ability for both the computer application and equipment interfaces a must.
Ability to provide off-hours support when needed.
Excellent verbal and written communication skills.
Proficiency in Microsoft Office Suite tools (Outlook, Word, Excel).