Lab Support Specialist - Pharma domain - NYTP

Job Title: Lab Support Specialist

Location: ONSITE in Fredrick, MD (5 days in office)

Experience: 9+ Years



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 issues



Understanding 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 environment,
Support managed services staff with the installation/configuration of regulated Lab/Manufacturing GMP systems



Work with vendor's tech support teams to resolve application errors as needed Administer updates on QC/Manufacturing instruments/systems such as user additions, removal, method/assay updates
Partner 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 personnel
Participate in process re-engineering workshops with business and IT stakeholders Perform impact assessment on changing product capabilities, including impact to integrated (boundary) systems
Respond 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 issues
Management 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 resources
Alignment with other manufacturing sites and corporate IT to ensure global consistency New or updated SOPs related to administration and installation of applications used in the



lab/manufacturing environments
Troubleshooting and replacement of hardware component and systems and system imaging software
AD account management and network connectivity requirements
Testing of phone and network patch cables to wall jacks
Troubleshooting and continuous updates to or creation of knowledge articles Timely and accurate communications with other parts of the organization regarding IT projects, timelines, and compliance