Workforce Genetics is currently seeking an experienced Data Integrity expert to support a 6-month project with a great organization located in the Baltimore, MD area.

The Data Integrity Consultant will support a project focused on compliance, system lifecycle management, and risk mitigation.

This is a hands-on, cross-functional role where your expertise in 21 CFR Part 11, ALCOA+ principles, and GAMP 5 will directly influence operational excellence and regulatory readiness across IT and OT systems.

Additional Responsibilities:

• Assess and map systems impacted by data integrity requirements
• Evaluate compliance across paper and digital documentation workflows
• Recommend and implement best practices for legacy equipment and data acquisition systems
• Lead corrective action planning and process improvement initiatives
• Act as SME in reviewing assessments, identifying gaps, and triaging risk
• Collaborate with cross-functional teams to ensure data reliability throughout the system lifecycle
• Provide technical input on GMP-compliant equipment and computerized systems
• Support process mapping and system decommissioning efforts
• Apply industry standards to enhance data governance and procedural adequacy

Experience Required:

• Deep knowledge of 21 CFR Part 11, ALCOA+, and GAMP 5
• Experience with Isolator Filling Equipment, HMIs, and GMP systems
• Strong understanding of CSV documentation: URS, IQ/OQ/PQ, risk assessments
• Proficiency in SQL, Excel, and other relevant tools
• Bachelor’s degree in Computer Science, Information Systems, or related field
• 5+ years in cGxP environments within biopharma or life sciences
• Ability to work independently, communicate clearly, and drive cross-functional collaboration