Lab Support Specialist Job at Katalyst HealthCares and Life Sciences, Frederick, MD

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  • Katalyst HealthCares and Life Sciences
  • Frederick, MD

Job Description

Responsibilities:
  • In-depth knowledge of GxP operations as it relates to the FDA's CFR 21 Part 11 requirements and well as Good Documentation Practices (GDP)
  • Good understanding of Windows Desktop OS support tasks (7 - Win 10) and ability to set up brand-new systems
  • Hands-on experience in the Installation and configuration of Lab/Manufacturing computer systems in a regulated GMP environment
  • Providing direct support to end-users ranging from Tier 1 - 2 type issues
  • Continue to develop an understanding of the business processes and all applicable procedures
  • In-depth knowledge of GxP operations as it relates to the FDA's CFR 21 Part 11 requirements and well as Good Documentation Practices (GDP)
  • Good understanding of Windows Desktop OS support tasks (7 - Win 10) and ability to set up brand-new systems
  • Install and configure Lab/Manufacturing computer systems in a regulated GMP environment
  • Oversee and 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
  • Serve as the System Owner/Manager and perform administrative tasks 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 instructions 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
  • Meet with internal clients and stakeholders to diagnose software and middleware issues
  • Align with other manufacturing sites and corporate IT to ensure global consistency
  • Review/develop SOPs related to the administration and installation of applications used in the lab/manufacturing environments
  • Troubleshooting and replacement of hardware components and systems
  • System imaging software experience and ability to learn new in-house method
  • Knowledge of simple AD account management and network connectivity requirements
  • Able to trace phone and network patch cables to wall jacks with the aid of network testing devices
  • In-depth knowledge of Microsoft O365 applications and other productivity applications such as Adobe Acrobat
  • Command of IT ticketing system use and effective workload management;
  • Proactively monitors and identifies trends and behaviors in systems support and addresses the findings or escalate to other IT team resources
  • Able to follow other specific troubleshooting steps and continuously update and create additional knowledge articles
  • Contributing to timely and accurate communications with other parts of the organization regarding IT projects, timelines, and compliance
Requirements:
  • MA/MS degree with 3+ years of Operations and/or Manufacturing, IT, and/or OAT (Operational automation Technology) experience OR
  • BA/BS degree with 5+ years of Operations and/or Manufacturing IT and/or OAT (Operational automation Technology) experience OR
  • High School Degree with 4+ years of IT Operations and/or Manufacturing IT and/or OAT (Operational automation Technology) experience
Katalyst HealthCares and Life Sciences

Job Tags

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