GXP Test Lead
Job in
Boca Raton, Palm Beach County, Florida, 33481, USA
Listed on 2025-12-02
Listing for:
Katalyst CRO
Full Time
position Listed on 2025-12-02
Job specializations:
-
IT/Tech
IT QA Tester / Automation, Systems Analyst, Data Analyst, Data Security
Job Description & How to Apply Below
Join to apply for the GXP Test Lead role at Katalyst CRO.
Responsibilities- 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, Neo Load).
- In‑depth understanding of Software Testing Life Cycle (STLC) process, QA tools and test management systems (e.g., JIRA, Client 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, Git Lab 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.
- 15+ years of software QA/testing experience, with at least 10+ years in regulated environments like life sciences, pharma, healthcare.
- 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, Neo Load).
- In‑depth understanding of Software Testing Life Cycle (STLC) process, QA tools and test management systems (e.g., JIRA, Client ALM, codebeamer).
- Proficient in Agile, Waterfall, or hybrid SDLC methodologies.
- Experience integrating automated testing into CI/CD pipelines (e.g., Jenkins, Git Lab CI).
- Knowledge of data privacy/security standards (HIPAA) relevant to software testing.
- Experience with risk‑based testing approaches in regulated environments.
- Experience in System Migration and Mobile Testing.
- Minimum requirement is a Bachelor's Degree in Computer Science, Sciences or a related education (e.g., life science, medicine);
Master's preferable. - GxP, Validation Testing, QMS, hands‑on in ALM/Codebeamer, Life Science Domain knowledge.
Mid‑Senior level
Employment TypeContract
Job FunctionQuality Assurance
IndustriesPharmaceutical Manufacturing
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