Lab Support Specialist

Job Title Top 3 Must Have's: 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 setup brand new systems Hands on experience in Installation and configuration of Lab/Manufacturing computer systems in a regulated GMP environment This position requires strong workstation support skills with key focuses including, but not limited to: 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 setup 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 need 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 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 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 administration and installation of applications used in the lab/manufacturing environments Troubleshooting and replacement of hardware component 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 address 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 Minimum Qualifications Education, Certifications &