IT Quality Assurance

Ameri-partners; Wisconsin; Hybrid; USD 110,000 - 140,000; Full time

Job summary

Ameri-partners is seeking an experienced IT Quality Assurance (IT QA) Specialist to support computerized systems within a regulated pharmaceutical environment. The role focuses on GxP, CSV/CSA, data integrity, and FDA 21 CFR Part 11 compliance.

Onboarding is onsite for the first two weeks, then remote work is possible. You will review validation artifacts, change controls, CAPAs, and system-related investigations while collaborating with IT, QA, CSV, and vendors.

Qualifications

• 5+ years IT QA, CSV, or Computer Systems Quality in pharma/biotech.
• Knowledge of GxP, SDLC/CSV, 21 CFR Part 11, GAMP 5, CAPA, deviations, and change control.
• Experience with LIMS, MES, SAP/ERP, QMS, EDMS, lab systems, or manufacturing apps.

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 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.

Skills

GxP knowledge

Regulatory compliance

Documentation

Auditing

Tools

LIMS

MES

SAP/ERP

QMS

EDMS

Laboratory systems

Manufacturing apps

Job description

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.