Configure and maintain QC Systems applications. Processes system change control, documents configuration, writes test plans, works as part of a team to implement and integrate new systems, develops coding solution when required.
• Maintain, support, enhance, template development of the Waters NuGenesis ELN application.
• Coordinate cross platform integration requirements, requirements gathering, system design and implementation.
• Complex configuration to meet end user requirements for QC System users.
• Responsible for QC System documentation, including, converting user Requirement Specifications to a Detail Design Specification, writing configuration Test Plans and summary reports.
• Configures reports (tabular, trend and labels.)
• Process QC System change control requests.
• Review of company documentation including SOPs, SPECs, Batchsheets and/or Manufacturing Records to assess QC System impact.
• Works with Validation and Quality Assurance departments to ensure QC System applications are implemented following development life cycle approach.
• Integrates new systems, instruments to QC Systems applications.
• Identification and implementation of areas for operational improvement of existing solutions.
• Develop custom GAMP 5 software solutions, Smalltalk, Java, Powerscript, .NET.
• Coordinates with Global IT team members to implement and maintain systems in an efficient manner.
• Provides end-user support for QC Systems including troubleshooting problems at the application, server, and infrastructure level.
• BS/BA in related field.
• Minimum 1-2 years of relevant experience.
• May substitute relevant industry experience for educational requirement.
• Waters NuGenesis Template configuration experience.
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