Qualitest · 7 hours ago
21305 - IT Quality Assurance (QA) Specialist
Beersheba Springs, TN
Full-time
Onsite
Mid Level
3+ years expQualitest is The World’s Leading AI-Powered Quality Engineering Company, seeking an IT Quality Assurance (QA) Specialist for their team. The role involves supporting QA oversight of computerized systems in regulated environments, ensuring compliance with relevant regulations, and collaborating with various stakeholders to improve QA processes.
ConsultingEnterprise SoftwareInformation ServicesInformation TechnologyOutsourcingQuality AssuranceSoftwareTest and Measurement
Responsibilities
Support QA oversight of computerized systems used in GxP-regulated environments (e.g., manufacturing, quality, supply chain, clinical, pharmacovigilance)
Review and approve validation deliverables, including URS, risk assessments, validation plans, test protocols, deviation reports, and validation summaries
Ensure compliance with relevant regulations and guidelines, including GxP, 21 CFR Part 11, EU Annex 11, and data integrity principles
Participate in system implementation, upgrades, changes, and periodic reviews from a quality perspective
Perform QA assessments of IT processes such as change management, incident management, access control, backup and recovery, and vendor management
Support internal and external audits and inspections related to computerized systems
Collaborate closely with IT, CSV, business stakeholders, and external vendors
Contribute to the continuous improvement of QA and validation processes and procedures
Support SOP authoring, review, and maintenance related to IT quality and validation
Qualification
Required
Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related field - Must
3–6 years of experience in QA, CSV, or IT Quality within a pharmaceutical or other regulated industry - Must
Hands-on experience with computerized system validation (CSV) - Must
Experience working in a GMP/GxP environment - Must
Strong knowledge of regulatory requirements: GxP, 21 CFR Part 11, EU Annex 11, data integrity (ALCOA+) - Must
Understanding of SDLC and risk-based validation approaches - Must
Strong attention to detail, analytical thinking, and documentation skills - Must
Ability to work independently and collaboratively in a cross-functional environment - Must
Good communication skills in English, both written and verbal- Must
Preferred
Familiarity with common pharmaceutical IT systems (e.g., ERP, QMS, LIMS, MES, clinical or PV systems) is an advantage
Benefits
Recognized among Israel's top 100 best places to work for, four years in a row
Be part of a company that is a globally recognized leader in Quality Engineering
Experience our team spirit, working with real people, and solving real challenges
Work with Senior Specialists and Practice Experts
Nurture your personal and professional growth through tailored career paths
Dive into interesting projects using cutting-edge technology designed by and for Quality Engineers
Enjoy unique placement opportunities worldwide
We believe in a workplace culture that values open communication and fairness, encouraging our employees to feel seen, supported, and empowered to realize their full potential
Company
Qualitest
Qualitest is the world’s leading managed services provider of AI-led quality engineering solutions.
5001-10000 employees
H1B Sponsorship
Qualitest 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
2025 (12)
2024 (36)
Funding
Current Stage
Late StageTotal Funding
unknown2019-07-10Acquired
Leadership Team
Andrew Duncan
Chief Executive Officer
Lihi Segev
Executive Vice President
Recent News
2025-07-14
Company data provided by crunchbase