Prevail InfoWorks · 6 hours ago
Quality Assurance Analyst
United States
Full-time
Remote
Mid Level
3+ years exp
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Responsibilities
Ensuring that testing practices are in compliance with regulatory statutes including 21 CFR Part 11 and 50, ICH E6 Guideline for Good Clinical Practices and company procedural documents.
Review and analyze system specifications, business requirements, and user stories.
Collaborate with development teams, business analysts, and stakeholders to understand project requirements and objectives.
Develop, document, and execute comprehensive test plans, test cases, and test scripts.
Perform various testing types, including functional, regression, integration, performance, and usability testing.
Identify, record, and track bugs using bug-tracking tools (e.g., Jira).
Verify defect fixes and perform regression testing in updated builds.
Participate in Agile/Scrum ceremonies, including sprint planning and retrospectives.
Ensure compliance with quality standards, processes, and procedures.
Provide regular status updates and test results to project stakeholders.
Perform duties as directed by the Director of Quality Assurance
Contribute to process improvement initiatives within the QA team and meet objectives as assigned
Qualification
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Required
Bachelor’s Degree in a scientific field (or equivalent educational background)
3-6 years of clinical research experience in a Quality Assurance role
Knowledge of FDA, ICH, HIPAA and GCP guidelines
Strong background in authoring Validation Plans and Summaries
Diverse experience with testing methodologies and manual and automated testing practices
Proactive and effective communicator, with excellent interpersonal skills
Knowledge of basic computer programs such as Word, Access, Excel, Power Point, and CRM
Ability to communicate and comprehend written and oral instructions
Able to effectively present information and respond to questions from colleagues and customers
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Able to apply common sense solutions towards the execution of responsibilities
Company
Prevail InfoWorks
Prevail InfoWorks is a system integration and analytics software company.
51-200 employees
H1B Sponsorship
Prevail InfoWorks has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Growth StageLeadership Team
Jack Houriet
Chief Executive Officer
Recent News
Company data provided by crunchbase
