More jobs:
IT Quality Assurance
Job in
Waukesha, Waukesha County, Wisconsin, 53188, USA
Listed on 2026-09-30
Listing for:
Ameri-partners
Full Time
position Listed on 2026-09-30
Job specializations:
-
IT/Tech
IT QA Tester / Automation, Data Analyst -
Quality Assurance - QA/QC
IT QA Tester / Automation, Data Analyst
Job Description & How to Apply Below
IT Quality Assurance (IT QA) Specialist – Pharmaceutical
Work Arrangement: First 2 weeks onsite for onboarding, system familiarization, and project kickoff; remote thereafter.
We are seeking an experienced IT Quality Assurance (IT QA) Specialist to support computerized systems and digital applications within a regulated pharmaceutical or biotechnology environment. The ideal candidate will have strong knowledge of GxP, Computer System Validation (CSV/CSA), data integrity, and FDA 21 CFR Part 11 requirements
.
Responsibilities
- Provide IT Quality oversight for GxP computerized systems throughout the system lifecycle.
- Review and approve validation documentation including URS, risk assessments, validation plans, IQ/OQ/PQ, test scripts, traceability matrices, and validation summary reports
. - Review and approve change controls, deviations, CAPAs, incidents, and system-related investigations
. - Ensure computerized systems comply with 21 CFR Part 11, GAMP 5, ALCOA+ data integrity principles, and applicable GMP requirements
. - Support periodic reviews, access/security reviews, audit-trail reviews, system assessments, and retirement activities.
- Provide QA oversight for system upgrades, patches, configuration changes, interfaces, and data migration.
- Collaborate with IT, QA, CSV, system owners, business users, and vendors.
- Support internal audits and regulatory inspections involving computerized systems.
Qualifications
- 5+ years of IT QA, CSV, or Computer Systems Quality experience in pharmaceutical, biotech, or life sciences.
- Strong knowledge of GxP computerized systems, SDLC/CSV lifecycle documentation, 21 CFR Part 11, GAMP 5, CAPA, deviations, and change control
. - Experience with LIMS, MES, SAP/ERP, QMS, EDMS, laboratory systems, or manufacturing applications preferred.
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