Job Description

Position Must Be Filled By April 15, 2016, So Apply Soon!

Position Summary:
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 document functional requirements and solution specifications, interacting with both Business users and IT resources. The Analyst will also oversee the administration of Veeva Vault, including managing the support provided by the vendor. Familiarity with computer systems validation principles, project management, and SDLC methodologies is essential.

Responsibilities:

1. Collaborate with internal business clients to document requirements for EDMS solutions and interfaced applications.
2. Analyze current processes; document configurations, application functionalities, and necessary modifications to support business needs.
3. Create SDLC project deliverables, including design, configuration, and testing documentation.
4. Engage with software vendors to understand existing and upcoming release functionalities.
5. Execute and document testing procedures; collaborate on problem resolution.
6. Provide technical assistance to users regarding errors, problems, or inquiries.
7. Perform Quality Assurance validation on software applications based on requirements.
8. Escalate incidents and requests to ensure quality service within established targets.
9. Participate in after-hours on-call support rotation as needed.
10. Offer technical and procedural guidance to team members during managerial absence.
11. Participate in knowledge transfer activities to support teams for implemented solutions.

Requirements:

• 2-5 years of relevant IT experience supporting and developing systems solutions to meet business requirements.
• 2-5 years of experience supporting or implementing enterprise software in regulated industries such as Pharmaceutical, BioTech, or Medical Devices.
• Understanding of IT Quality Methodology and Change Management processes and tools.
• Previous experience in Application Maintenance and Support is essential.
• Experience with systems supporting Trackwise is a plus.
• College degree or equivalent experience.
• At least 3 years of EDMS experience, with Veeva Vault experience being advantageous.

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