Essential Functions: |
• Serve as IT System Owner for Quality, Laboratory and Regulatory IT Applications, providing lifecycle management from system selection through final decommissioning. |
• Drive successful, timely and efficient system implementation, including project coordination, technical support, vendor management and project timeline/budget adherence. |
• Lead process improvements and change management for assigned applications, to assure realized compliance and business value of such applications. |
• Provide routine administrative and operational support to computer systems throughout the laboratory, R&D, RA and Quality organization including but not limited to |
• Operate Thermal Mapping equipment, i.e., Kaye in performing temperature mapping on sterilizers, depyrogenation tunnels, lyophilizers, incubators, stability chambers, areas, rooms, etc.
- Chromatography Data Systems such as Thermo Chromeleon, Waters Empower, and Agilent OpenLab and EZ Chrom Chromatography Data Systems
- Niche Laboratory data acquisition, processing and reporting systems associated with specific laboratory equipment such as LabX Titration, ColorQuest, Omnic FI-IR, ICP- MS,
- Quality software such as Calibration Manager (Calman/AMMS), Scientek iStability and other LIMS software.
- Compliance software such as TrackWise Enterprise, eQMS, EDMS VeevaVault QMS/QDocs and Learning Management Systems.
- Optel line master and serialization product suite.
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• Propose application-based solutions for business processes to enhance efficiency, compliance, and visibility to processes. |
• Partner with business process owners, and key IT stake holders for effective collaboration throughout system design, configuration, deployment and maintenance. |
• Solicit end-user feedback to drive collaborative value-added continual improvement within applications in assigned functional areas. |
• Provide application trouble shooting support, partnering with global IT resources, vendors and other available SMEs to resolve issues, investigate failures and implement appropriate preventative actions. |
• Collaborate with quality team to provide SME contributions related system-failure related deviations, providing insight into root cause analysis, and partner with business to identify most appropriate CAPA for risk mitigation. |
• Publish business success playbooks and associated tools for system use/end-user support |
• Evaluate system use through a combination of system reporting data analysis and end user feedback |
• Document resolutions in a manner to facilitate appropriate creation of internal knowledgebase for applications. |
• Application lifecycle maintenance including but not limited to, review application release notes, with business process SMEs and data system specialists to advise on change impact, and upgrade recommendations to maintain systems within infrastructure standards, where possible. |
• Desktop / server / networking configuration, support and change management in a highly- regulated environment. |
• Other duties, as needed to support continued operational excellence, compliance. |