Role: Lab Support Specialist

Location: Frederick, MD - Day 1 ONSITE

**1.looking for profiles with customer service experience & GxP system troubleshooting

2. Profiles with some programing experience.**

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 & Experience

• 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

Years of Experience: 9.00 Years of Experience