Sr. Analyst, IT Business-EDMS

14 Mar 2016 - Full-Time Sr. Analyst, IT Business-EDMS
San Francisco, California, United States

The Senior Business Analyst, Quality Systems (IT) position will be responsible for defining, designing, and delivering information technology solutions in a validated environment for the Quality, R&D and Manufacturing areas, with primary responsibility for EDMS systems. The Analyst will be responsible for documenting functional requirements and solution specifications, interacting with both Business users and IT resources. The Analyst will also be responsible for the administration of Veeva Vault including overseeing the managed services vendor aiding in that support.

The Analyst should be familiar with the principles of computer systems validation, project and SDLC methodologies.

• Work with internal business clients to document business requirements for EDMS solutions and applications interfaced with it.
• Analyze current processes, and document configuration, application functionality and integration modifications needed to support business requirements.
• Create SDLC project deliverables including design, configuration, and testing.
• Work with software vendors to understand existing and future release functionality.
• Execute and document testing and work with team members for problem resolution.
• Provides technical assistance to users inquiries regarding errors, problems or questions.
• Perform Quality Assurance validation on requirements based software applications.
• Escalate incidents and requests as required to ensure quality service and within established service targets.
• Participate in after-hours on-call support rotation as required.
• Provide technical and procedural direction to team during manager’s absence.
• Participate in knowledge transfer activities to relevant support teams for implemented solutions.

• 2‑5 years of relevant IT experience supporting/developing systems solutions to business requirements.
• 2‑5 years of supporting or implementing enterprise software in a regulated industry (preferably Pharmaceutical/Bio Tech/Medical Device).
• 2‑5 years of understanding of IT Quality Methodology and Change Management, including processes and tools.
• Previous application maintenance/support experience a must.
• Experience with systems supporting Trackwise is a plus.
• College degree (or equivalent experience).
• Minimum 3 years of previous EDMS experience – Veeva Vault experience is a plus.
• 0‑2 years of IT certifications/training or equivalent experience is a plus.