Responsibilities:

• Configure and support existing and new GxP software applications based on user, regulatory, and business requirements.
• Work with IT and other appropriate personnel to facilitate integration between different systems.
• Understand system database structures, processes, and practices to allow for creation of reports, as appropriate, and for troubleshooting
• Understand database backup and restore procedures and processes.
• Create, revise, and maintain system reports.
• Assist with disaster recovery application testing, as necessary.
• Coordinate with users & IT with regards to technical issues, as necessary.
• Create, execute, and maintain validation scripts necessary for compliance with applicable regulations and requirements.
• Test & validate software upgrades and patches, working closely with IT, outside consultants/vendors, and users as appropriate.
• Assist with administration of user accounts and periodically perform divisional reviews to assure accounts are up-to-date, as needed.
• Follow and participate in Departmental office procedures and policies on daily basis.
• Special projects for Corporate Quality Systems Department on monthly basis or as required.
• Other duties as assigned

Requirements:

• Bachelor’s degree (B.S) in the Sciences or IT field from four-year College or university.
• A minimum of five years of experience working with SmartSolve or EtQ eQMS platforms and/or related systems in a GxP environment.
• To perform this job successfully, an individual should have in-depth knowledge of Spreadsheet software, Word Processing software, and Database Software and standards, preferably Microsoft Access and SQL.
• Have an understanding of basic coding concepts (i.e. Understanding of VB, C++, Perl, or any similar programming language) and have the ability to learn new coding language as needed.
• Databases: Understand the concept of relational databases. Understand and write SQL.
• Experienced in writing change controls, validation plans, scripts and execution of scripts.