Sr Quality Assurance Engineer; Pharma mandatory
Job in
Chicago, Cook County, Illinois, 60601, USA
Listed on 2026-11-01
Listing for:
Innovator Web Solution
Full Time
position Listed on 2026-11-01
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, IT QA Tester / Automation, Data Analyst
Job Description & How to Apply Below
Pharma experience is mandatory which includes FDA 21 CFR Part 11, GLP, GMP and GCP.
Key Responsibilities- Design, develop, and execute test cases for database and data-driven applications.
- Perform Database Testing, ETL Testing, and Data Validation.
- Write and execute complex SQL queries to validate data accuracy, completeness, and integrity.
- Validate data across source and target systems as part of ETL and data migration testing.
- Identify, document, track, and report defects through the complete defect lifecycle.
- Work closely with development, business, and other QA teams to investigate and resolve issues.
- Ensure testing activities comply with applicable Pharma industry quality and regulatory standards.
- Participate in test planning, execution, defect management, and reporting.
- Contribute to continuous improvement of QA processes and best practices.
- 6+ years of experience in Software Quality Assurance/Testing.
- Mandatory Pharma domain experience.
- Strong hands‑on experience in:
Database Testing, ETL Testing, SQL & Data Validation. - Good understanding of GxP (Good Practice) requirements within the Pharma/Life Sciences domain.
- Working knowledge of one or more of the following: GLP Good Laboratory Practice, GCP Good Clinical Practice & GMP Good Manufacturing Practice.
- Understanding of FDA 21 CFR Part 11, particularly requirements related to:
Electronic records, Electronic/digital signatures, Data integrity and compliance. - Strong analytical and problem‑solving skills.
- Excellent verbal and written communication skills.
- Ability to work independently in a remote environment and collaborate effectively with distributed teams.
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