SAP BODS
Job in
Frisco, Collin County, Texas, 75034, USA
Listing for:
TechDigital Group
Full Time
position
Listed on 2025-12-18
Job specializations:
Salary/Wage Range or Industry Benchmark: 50000 - 90000 USD Yearly
USD
50000.00
90000.00
YEAR
Job Description & How to Apply Below
Must Have's:
GxP experience - GxP operations as it relates to the FDA's CFR 21 Part 11 requirements and Good Documentation Practices (GDP)Desktop Support - tier 1/tier 2 in a GMP environment (Windows Desktop OS support tasks (Win 7 – Win 11) Including the setup of new systems, installation and configuration of QC Lab/Manufacturing computer systems in a regulated GMP environment)JD:
Project Scope:
Kites IT Tech Ops team needs onsite Lab Support Specialists. The scope includes efficient and reliable operation of internal desktop lab systems and will handle tactical matters such as service requests as well as when working on larger projects.
Scope of Services
Workstation support, including direct support to end-users ranging from Tier 1 - 2 type issuesUnderstanding of the business processes and all applicable procedures, including in-depth knowledge of GxP operations as it relates to the FDA's CFR 21 Part 11 requirements and Good Documentation Practices (GDP)Windows Desktop OS support tasks (Win 7 – Win 11) Including the setup of new systems, installation and configuration of QC Lab/Manufacturing computer systems in a regulated GMP environmentSupport managed services staff with the installation/configuration of regulated Lab/Manufacturing GMP systemsWork with vendor's tech support teams to resolve application errors as neededAdminister updates on QC/Manufacturing instruments/systems such as user additions, removal, method/assay updatesPartner with local QA/QE to evaluate and test new upgrades/patches to Operating Systems/applications and write install instruction for Lab/MFG managed services support personnelParticipate in process re-engineering workshops with business and IT stakeholdersPerform impact assessment on changing product capabilities, including impact to integrated (boundary) systemsRespond to IT support requests to address operational issues with enterprise and quality applications and meet with internal clients and stakeholders to diagnose software and middleware issuesManagement of Sparc ticketing system for effective workload management; proactive monitoring and trend identification and analysis of behaviors in systems support. Resolution of findings or escalation to other IT team resourcesAlignment with other manufacturing sites and corporate IT to ensure global consistencyNew or updated SOPs related to administration and installation of applications used in the lab/manufacturing environmentsTroubleshooting and replacement of hardware component and systems and system imaging softwareAD account management and network connectivity requirementsTesting of phone and network patch cables to wall jacksTroubleshooting and continuous updates to or creation of knowledge articlesTimely and accurate communications with other parts of the organization regarding IT projects, timelines, and compliance#J-18808-Ljbffr
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