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Application Testing Specialist

Job Description

Hiring Manager Comments:


* Degree in computer science, information technology, life science or 5 years-experience in software quality assurance in the life sciences industry

* Working knowledge of GAMP5 concepts, 21 CFR Part 11 and ITIL
* Must have change management experience, preferably ServiceNow change management experience
* Experience with electronic document management systems and testing applications such as HP ALM/HP Quality Center is a plus

* Strong oral and written communication skills in English



Job Description:

Position responsibilities include:
* Working with the Infrastructure and Hosting Services (IS) teams and Enterprise Service Providers) to assess new and existing server rooms/Data Centers, infrastructure components installations (server, DB and storage) and application tool installations and upgrades. Execute the qualification process as applicable, ensuring change requests are submitted per policy
* Perform quality review and approval of related change tickets
* Ensure any deviations are documented, remediated and closed
* Track and ensure qualified assets have an appropriate disposition
* Ensure the qualification of infrastructure software or applications that interface/impact GxP applications
* Ensure qualification documentation is efficiently managed and available for inspection
* Ensure server room monthly access reviews are accurate and executed in a timely fashion. Route for applicable approvals
* Execute tri-annual server room quality inspections, checking/testing elements of physical security and facility-related equipment controls. Track observations through to remediation
* Participate in status calls representing IT Quality Management
* Serve as a qualification subject matter expert
* Maintains close communication with stakeholders and team members to keep apprised of status and timelines
* Reports status to management
* Assist in the preparation of summary reports

Qualifications
* Degree in computer science, information technology, life science or 5 years-experience in software quality assurance in the life sciences industry
* Technically conversant in infrastructure concepts and techniques related to server rooms/data centers, servers, databases & storage devices
* Working knowledge of GAMP5 concepts, 21 CFR Part 11 and ITIL
* Must have change management experience, preferably ServiceNow change management experience
* Previous experience supporting computer system validation efforts including authoring qualification deliverables
* Strong oral and written communication skills in English
* Proficiency in MS Office suite
* Experience with electronic document management systems and testing applications such as HP ALM/HP Quality Center is a plus
* Open to creative, innovative, flexible and practical approaches to improving practices and solving problems

Job Requirements

 

Job Snapshot

Location US-NJ-Princeton
Employment Type Contractor
Pay Type Year
Pay Rate N/A
Store Type IT & Technical
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Company Overview

AIC (part of ACS Group)

Analysts International Corporation (AIC) is an IT services firm fully dedicated to the success and satisfaction of its customers. From IT staffing to project-based solutions, AIC provides a broad range of services designed to help businesses and government agencies drive value, control costs and deliver on the promise of a more efficient and productive enterprise. Learn More

Contact Information

US-NJ-Princeton
AIC
(404)585-5612
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Snapshot
AIC (part of ACS Group)
Company:
US-NJ-Princeton
Location:
Contractor
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
IT & Technical
Store Type:

Job Description

Hiring Manager Comments:


* Degree in computer science, information technology, life science or 5 years-experience in software quality assurance in the life sciences industry

* Working knowledge of GAMP5 concepts, 21 CFR Part 11 and ITIL
* Must have change management experience, preferably ServiceNow change management experience
* Experience with electronic document management systems and testing applications such as HP ALM/HP Quality Center is a plus

* Strong oral and written communication skills in English



Job Description:

Position responsibilities include:
* Working with the Infrastructure and Hosting Services (IS) teams and Enterprise Service Providers) to assess new and existing server rooms/Data Centers, infrastructure components installations (server, DB and storage) and application tool installations and upgrades. Execute the qualification process as applicable, ensuring change requests are submitted per policy
* Perform quality review and approval of related change tickets
* Ensure any deviations are documented, remediated and closed
* Track and ensure qualified assets have an appropriate disposition
* Ensure the qualification of infrastructure software or applications that interface/impact GxP applications
* Ensure qualification documentation is efficiently managed and available for inspection
* Ensure server room monthly access reviews are accurate and executed in a timely fashion. Route for applicable approvals
* Execute tri-annual server room quality inspections, checking/testing elements of physical security and facility-related equipment controls. Track observations through to remediation
* Participate in status calls representing IT Quality Management
* Serve as a qualification subject matter expert
* Maintains close communication with stakeholders and team members to keep apprised of status and timelines
* Reports status to management
* Assist in the preparation of summary reports

Qualifications
* Degree in computer science, information technology, life science or 5 years-experience in software quality assurance in the life sciences industry
* Technically conversant in infrastructure concepts and techniques related to server rooms/data centers, servers, databases & storage devices
* Working knowledge of GAMP5 concepts, 21 CFR Part 11 and ITIL
* Must have change management experience, preferably ServiceNow change management experience
* Previous experience supporting computer system validation efforts including authoring qualification deliverables
* Strong oral and written communication skills in English
* Proficiency in MS Office suite
* Experience with electronic document management systems and testing applications such as HP ALM/HP Quality Center is a plus
* Open to creative, innovative, flexible and practical approaches to improving practices and solving problems

Job Requirements

 
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