ZTEK- 58739 Lab Support Specialist - Ztek Consulting INC
Frederick, MD
About the Job
Job Title: Lab Support Specialist
Duration: 6-12 months
Location: Onsite -Fredrick, MD
Work Type:
Rate: Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Job Summary:
GxP experience - GxP operations as it relates to the FDA's CFR 21 Part 11 requirements and Good Documentation
Practices (GDP)
Desktop Support - tier 1/tier 2 in a GMP environment (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)
Duration: 6-12 months
Location: Onsite -Fredrick, MD
Work Type:
Rate: Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Job Summary:
GxP experience - GxP operations as it relates to the FDA's CFR 21 Part 11 requirements and Good Documentation
Practices (GDP)
Desktop Support - tier 1/tier 2 in a GMP environment (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)
JD:
Project Scope:
Kites IT Tech Ops team needs onsite Lab Support Specialists. 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
Project Scope:
Kites IT Tech Ops team needs onsite Lab Support Specialists. 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
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
ABOUT Ztek:
Website: www.ztekinc.com
Ztek Consulting Inc is a minority- and woman-owned business enterprise that leverages a unique blend of human talent, machine learning algorithms, and artificial intelligence to provide customized talent management solutions for clients. Ztek's diversity-focused hiring models have proven successful, particularly in hiring veterans. The company's veteran-focused hiring and deployment program, Z-V.E.T, matches skilled veterans with clients' needs in various areas.
Website: www.ztekinc.com
Ztek Consulting Inc is a minority- and woman-owned business enterprise that leverages a unique blend of human talent, machine learning algorithms, and artificial intelligence to provide customized talent management solutions for clients. Ztek's diversity-focused hiring models have proven successful, particularly in hiring veterans. The company's veteran-focused hiring and deployment program, Z-V.E.T, matches skilled veterans with clients' needs in various areas.
Disclaimer:
Ztek is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Ztek is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hrd@ztekinc.com Please indicate the specifics of the assistance needed. Ztek encourages all interested and qualified candidates to apply for employment opportunities. Ztek does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. 1324b.
Ztek is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Ztek is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hrd@ztekinc.com Please indicate the specifics of the assistance needed. Ztek encourages all interested and qualified candidates to apply for employment opportunities. Ztek does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. 1324b.
Source : Ztek Consulting INC