This role can be done completely remotely from any of the following locations: East coast US, West Coast US, Netherlands, UK, Switzerland, and Ireland.
Key Accountabilities of the Software Upgrade Tester include the following:
System and Study Upgrades
- Testing of software upgrades to client live Randomization and Trial Supply Management (RTSM) applications
- Work with Software Upgrade Test Manager and Test Designer to test software upgrades applied to live studies, ensuring applications are tested appropriately per the upgrade test design.
- Responsible for software upgrade testing, including hotfixes, maintenance patches, minor and major upgrades.
- Identify defects and recreate for engineers as necessary.
- Work with Test Designers to confirm test data to be staged, if appropriate.
- May develop study specific validation plans, test strategies and test cases.
- Execute study testing, following the clients SOPs.
- Prepare the system for UAT, in coordination with the development team as necessary.
Identify operational business needs and collaborate with product development to influence RTSM product feature development, prioritization and strategy to ensure that the product meets client capability needs, improve the system’s efficiency and user-friendliness.
Previous experience in software development, quality assurance, or other related fields. Experience working with Atlassian tools and test documentation software.
EDUCATION AND/OR CERTIFICATION REQUIREMENTS
The candidate must possess at minimum a bachelor’s degree in a life science, supply chain management, or information technology field, or equivalent experience.
- Excellent verbal and written communication skills. Strong root cause analysis skills.
- Knowledge of US FDA Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) GCP regulations, Electronic Records; Electronic Signatures regulation (21 CFR Part 11) and EU Annex 11, and associated regulatory guidance documents