What are the responsibilities and job description for the Lab Support Specialist position at Katalyst Healthcares & Life Sciences?
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
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
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