Quality IT Business Systems Analyst, Kite Quality ITUnited States – RemoteInformation TechnologyRegular
Quality IT Business Systems Analyst, Kite Quality IT
We are seeking a highly motivated individual to join us as the Quality IT Business Systems Analyst for the Kite Information Technology group. The Quality IT Business Systems Analyst will be accountable for developing, supporting and advising on a LabVantage LIMS application to meet and enable business needs. This role provides system expertise, best-fit solutions and oversight of development. This will be a critical role within Kite IT supporting one of Kite’s top enterprise applications.
KEY RESPONSIBILITIES include but are not limited to:
- Provide best practices on LIMS development, master data, report and any other configuration
- Work closely with Quality organization to develop and configure LabVantage LIMS application based on business requirements
- Own change management for LIMS and other Quality IT applications
- Manage system developers by guiding development solutions and reviewing delivered functionality ensuring standards are met and proper logic is utilized
- Collaborate closely with other IT groups (Infrastructure, Service Desk, IT Security, and Portfolio Management) on the infrastructure and database requirements
- Develop code using an object-oriented languages such as Java and Groovy
- Lead peer reviews of code for coding standards, best practices, functionality, error handling, etc.
- Write and perform validation testing for system functionality
- Lead and assist gathering business requirements and translate to functional requirements
- Write basic SQL queries using relational database concepts and schema design principles
- Integrate laboratory instruments with scientific software packages
- Uphold IT governance and change control amongst IT and business teams to prioritize and implement development.
- Assist in developing SOPs, work instructions and other relevant documentation for quality systems administration.
- BS in Life Sciences, Engineering, or Computer Science with 5 years of experience in a GxP regulated setting (Laboratory, Quality, Manufacturing, IT)
- MS in Life Sciences, Engineering, or Computer Science with 3 years of experience in a GxP regulated setting (Laboratory, Quality, Manufacturing, IT)
- BS a Life Sciences, Engineering, Computer science
- Minimum of 4 years of working within a GxP regulated setting (Laboratory, Quality, Manufacturing, IT)
- A working level understanding of 21 CFR Part11, GAMP and ITIL
- Experience implementing and supporting LabVantage LIMS systems. Strong preference on version 8.4 or greater
- Understanding of LabVantage specific infrastructure requirements and recommendations a plus
- Ability to handle balancing conflicting priorities
- Experience in implementing and leading change management and governance process
- Strong written and verbal communication and presentation skills