IT Quality Assurance Specialist

Position: IT Quality Assurance Specialist / Lead

Location:

NC

The ITQA professional will ensure that computerized systems, IT infrastructure and digital technologies used across pharmaceutical manufacturing operations remain compliant with applicable GxP requirements throughout their lifecycle. The role will provide independent quality oversight for system validation, data integrity, change control, deviations, periodic reviews, access management, backup and recovery, cybersecurity controls and supplier governance.

The position will collaborate with Quality, IT, Manufacturing, Engineering, QC, Warehouse, Automation and business process owners to maintain systems in a validated and inspection-ready state.

• Provide ITQA oversight for GxP computerized systems, including ERP/SAP, MES, LIMS, QMS, DMS, laboratory systems, manufacturing applications, historians, BMS, EMS, SCADA and other automation platforms.
• Review and approve validation lifecycle deliverables such as:
• GxP and data-integrity assessments
• User Requirement Specifications
• Validation plans and summary reports
• Functional and design specifications
• Configuration specifications
• IQ, OQ and PQ protocols and reports
• Requirements traceability matrices
• System release and retirement documentation
• Ensure validation activities follow a risk-based approach aligned with GAMP 5 and applicable internal procedures.
• Support the transition from traditional CSV practices to Computer Software Assurance, where appropriate.

• Ensure IT systems and infrastructure comply with applicable GxP regulations, company quality standards and approved procedures.
• Review and approve GxP-related IT changes, incidents, deviations, CAPAs and problem investigations.
• Assess the quality and compliance impact of proposed system changes, upgrades, patches, migrations and integrations.
• Monitor the validated state of computerized systems throughout their operational lifecycle.
• Participate in system implementation, cloud adoption, infrastructure modernization and digital-transformation projects.
• Ensure appropriate quality oversight of legacy-system remediation and system decommissioning.

• Evaluate systems against ALCOA+ data-integrity principles.
• Ensure adequate controls for electronic records and electronic signatures.
• Review controls relating to:
• User access and role-based privileges
• Administrator and privileged accounts
• Segregation of duties
• Audit trails and audit-trail review
• Date and time synchronization
• Data backup, restoration and archival
• Record retention and retrieval
• Interface and data migration controls
• Disaster recovery and business continuity
• Support investigations involving electronic records, audit trails, unauthorized access or suspected data-integrity concerns.

• Review and approve IT-related SOPs, policies, work instructions and technical procedures.
• Participate in deviation investigations, root-cause analysis and CAPA development.
• Track IT compliance actions and CAPAs through effective closure.
• Coordinate periodic reviews of GxP computerized systems and infrastructure.
• Support risk-based evaluation of obsolete technologies, unsupported platforms and compliance vulnerabilities.
• Develop and monitor IT quality metrics, compliance dashboards and management-review inputs.

• Support internal audits, supplier audits, regulatory inspections and customer assessments.
• Prepare and maintain validation and compliance evidence in an inspection-ready state.
• Coordinate responses to observations related to computerized systems, electronic records and IT controls.
• Conduct IT GxP compliance assessments and follow up on…