Data Integrity Professional

Role Summary

The Data Integrity Professional ensures the accuracy, consistency, and reliability of data across systems and processes, supporting FDA regulatory compliance, quality assurance, quality control, and continuous improvement in data governance practices. This is a first-shift opening.

Responsibilities

• Leading and facilitating data integrity risk assessments across Operational QA/QC systems and processes.
• Conducting internal audits focused on data integrity compliance and identifying areas for improvement.
• Collaborating cross-functionally to investigate data discrepancies and implement effective corrective and preventive actions (CAPAs).
• Providing strategic direction and oversight for site-wide data integrity initiatives, including risk mitigation planning and execution.
• Supporting continuous improvement efforts by promoting best practices in data governance and regulatory compliance.
• Communicating findings and recommendations clearly to stakeholders at all levels, ensuring alignment and accountability.

Qualifications

• Basic knowledge of manufacturing, packaging and quality testing systems in a pharmaceutical environment.
• Working knowledge of FDA regulatory standards.
• Excellent communication skills, including the ability to collaborate effectively with staff at all levels and strong technical writing skills.
• Computer literacy.
• Four-year degree in a scientific or closely aligned field.
• A minimum of five years’ experience in an FDA-regulated industry.
• Experience in the interpretation and application of FDA requirements and cGMP is preferred.

Skills

• Familiarity with SAP, LIMS, TrackWise and Empower.
• Analytical and data governance skills.
• Strong written and verbal communication; ability to prepare clear, precise documentation.
• Problem-solving and collaboration across cross-functional teams.

Education

• Bachelor’s degree in a scientific field or closely aligned discipline.