GxP Test Lead
Boca Raton,FL (Initial Remote)
Contract
Primary & Secondary Skill:
GxP, Validation Testing, QMS, Hand on in ALM/Codebeamer, Life Science Domain.
Job Description:
15+ years of software QA/testing experience, with at least 10+ years in regulated environments like life sciences, pharma, healthcare.
Strong expertise in GxP compliance, CSV, and FDA 21 CFR Part 11 standards.
Strong leadership, test planning, estimation, and cross-functional communication skills.
Experience in testing SAAS/COTS/Bespoke , CRM , Life sciences systems, or lab systems (e.g., StarLIMS, Salesforce Health Cloud).
Hands-on proficiency in functional testing, test automation and performance testing tools (e.g., Tosca, NeoLoad).
In-depth understanding of Software Testing Life Cycle (STLC) process, QA tools and test management systems (e.g., JIRA, HP ALM, codebeamer).
Proficient in Agile, Waterfall, or hybrid Software Development Life Cycle (SDLC) methodologies.
Experience integrating automated testing into CI/CD pipelines (e.g., Jenkins, GitLab CI).
Knowledge of data privacy/security standards (e.g., HIPAA) relevant to software testing.
Experience with risk-based testing approaches in regulated environments.
Experience in System Migration and Mobile Testing
Qualification:
Minimum requirement is a Bachelor’s Degree in Computer Science, Sciences or a related education (e.g. life science, medicine) , Masters preferable
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