Role: Lab Support Specialist

Location: (Frederick, MD – Onsite)

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 willhandle 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

Years of Experience: 9.00 Years of Experience