Hi,
Send resume to [email protected] ASAP.

*QA Tester *

San francisco, California

12+ months

* *

QA tester position with knowledge of Informatics Clinical Operations. Apply
software testing principals and test case design concepts to complete the
deliverables for the data migration from Oracle Clinical to Rave EDC
systems.

*Required Skills*



• Responsible for all aspects of document creation and review of User
Requirements, Migration Plans, Test Plans and Validation Protocols
according to System Development Life Cycle and Computer System Validation
regulations and using document templates.
• Responsible for developing test protocols, scenarios and scripts to test
migration tools as well as study-specific migrations.
• Responsible for execution of the test plans and validation protocols
according to documentation practices.
• Work with technical team to analyze test deviations and document
resolutions.
• Create test summary documentation and obtain final approvals.
• Makes sure that applicable regulations, guidelines and internal
procedures related to quality assurance (QA) and validation are followed
and applied.
• Works with IT project teams, database administrators, validation and QA
staff.
• A good understanding of the principles of software validation in
regulated industries is a plus, including 21 CFR Part 11, PDA 18, related
FDA guidelines and regulations, as well as ICH GCP guidelines.

*Desired Skills*

CRM functional skills

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