Quality Assurance Validation & Data Integrity Engineer II

Baxter International; Round Lake (IL); Presencial; USD 88.000 - 121.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health benefits

401(k) plan

ESPP

Descripción de la vacante

Baxter International in Round Lake, IL is hiring a Quality Assurance Validation & Data Integrity Specialist to partner across validation, qualification and data integrity activities, ensuring regulatory compliance. You will review documentation, assess risk, and support inspections while improving quality across equipment, facilities, and computerized systems.

You will lead risk-based decision making, strengthen control of quality records, and collaborate with cross-functional teams to sustain

Formación

• Bachelor's degree or higher in Engineering, Science, CS, or related technical discipline.
• 3+ years in QA, Validation, Quality Engineering, Data Integrity or related roles in a cGMP environment.
• Knowledge of cGMP, GAMP5, 21 CFR Part 11, ALCOA+ data integrity, risk-based quality management.

Responsabilidades

• Provide QA leadership for validation and qualification projects from risk assessment to project closure.
• Review validation, qualification and lifecycle docs to ensure compliance with cGMP and regulatory expectations.
• Evaluate change controls, validation impact assessments, and risk-based decision making.
• Approve eQMS records with clear accountability across stakeholders.
• Lead data integrity assessments and verify corrective actions and sustainable controls.
• Analyze trends in validation deviations and quality system metrics to identify risks.
• Support regulatory inspections with subject matter expertise and inspection-ready documentation.

Conocimientos

Quality Assurance

Validation

Data Integrity

Risk Assessment

Regulatory Compliance

Analytical Thinking

Educación

Bachelor's degree in Engineering/Science/Computer Science

Herramientas

eQMS platforms

Audit trail review programs

computerized systems validation

Descripción del empleo

Baxter International in Round Lake, IL is hiring a Quality Assurance Validation & Data Integrity Specialist to partner across validation, qualification and data integrity activities, ensuring regulatory compliance. You will review documentation, assess risk, and support inspections while improving quality across equipment, facilities, and computerized systems.

You will lead risk-based decision making, strengthen control of quality records, and collaborate with cross-functional teams to sustain