Lab System Support/ Site MFG & QC Lab Support

Keylent, Inc.

$156K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • 5+ years of hands-on experience in a Good Manufacturing Practice (GMP) environment
  • Strong knowledge of FDA's CFR 21 Part 11 and Good Documentation Practices (GDP)
  • Proficiency in Windows Desktop OS support (Win 7 - Win 11)
  • Experience with lab systems related to quality control and manufacturing
  • Familiarity with ticketing systems for IT support
  • Ability to manage end-user IT support issues from Tier 1 to Tier 2

Responsibilities

  • Provide direct workstation support for lab systems and troubleshoot Tier 1 - 2 issues
  • Install, configure, and support regulated GMP computer systems
  • Collaborate with managed services staff for lab equipment setups
  • Respond to IT support requests related to enterprise applications
  • Administer user management and updates for QC/Manufacturing systems
  • Participate in workshops for process improvement and technology upgrades
  • Monitor and analyze IT support trends to ensure system reliability

Benefits

  • Onsite work in a collaborative lab environment five days a week
  • Strong emphasis on compliance and regulatory practices
  • Opportunities for participation in process re-engineering workshops
  • Engagement with cross-functional teams for system upgrades
  • Fostering a culture of communication around IT projects and timelines
Full Job Description
Job Title: Lab System Support/ Site MFG & QC Lab Support - STC
Max Supplier Bill Rate - $75 (USE THIS VS RATE CARD)
• Location: El Segundo, CA - onsite 5 days a week
• Standard laptop
• BGV fully cleared


Must Have's:
The hiring team would like to emphasize that the QC Lab related activities listed on the JD are crucial as well as predominantly Lab Support experience (so hands on GxP is mandatory). Please be sure your candidates have this experience before submitting. Thank you in advance!

Project Scope:
Kites IT Tech Ops team needs onsite Lab Support Specialists for the MVP01 (Oceanside) and RDMC (Santa
Monica) QC Labs. 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

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