Data Steward: LIMS & Compliance Specialist

Guerbet; Raleigh (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Guerbet seeks a Data Steward to ensure data integrity and regulatory compliance across QC systems, including LIMS, SAP Quality Management, and eQMS. You will act as a SME, drive data governance, and collaborate with Quality, Manufacturing, Regulatory Affairs, IT, and Supply Chain to enable reliable data-driven decisions.

You will lead data integrity initiatives, maintain data standards, support audits, and contribute to system validation and upgrades while aligning with FDA 21 CFR Part 11 and

Qualifications

• Bachelor's degree required; degree in a scientific, technical, or related field preferred.
• Minimum of five (5) years of experience in a pharmaceutical, biotechnology, medical device, or other regulated environment.
• Working knowledge of cGMP, FDA regulations, data integrity requirements, and quality management systems.
• Experience with LIMS, SAP Quality Management, eQMS, and electronic data management systems.
• Knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, and ALCOA+ data integrity principles.
• Strong analytical, organizational, troubleshooting, and problem-solving skills.
• Effective written and verbal communication skills with the ability to work cross-functionally.
• Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint.

Responsibilities

• Administer and maintain LIMS with data accuracy, integrity, security, and regulatory compliance.
• Ensure compliance with LIMS and linked electronic systems.
• Identify and investigate data or operational anomalies; recommend corrective actions and support validation, control, and audit activities for LIMS within QC.
• Serve as SME for LIMS; provide troubleshooting and ongoing support for the live system.
• Act as QA SME for SAP Quality functions, including review of system changes, master data management, troubleshooting, enhancements, and upgrades.
• Train users on electronic systems, data management processes, and quality requirements.
• Support implementation, validation, and maintenance of new electronic systems and upgrades.
• Author, revise, review, and maintain laboratory procedures and supporting documentation for electronic data systems and quality operations.
• Ensure compliance with FDA regulations, cGMP, data integrity principles, and internal quality management systems.
• Support internal audits, regulatory inspections, data integrity assessments, and remediation activities as required.

Skills

Analytical thinking

Cross-functional collaboration

Troubleshooting

Written and verbal communication

Problem-solving

Education

Bachelor's degree in science or related field

Tools

LIMS

SAP Quality Management

eQMS

CSV

Microsoft Office

Job description

Guerbet seeks a Data Steward to ensure data integrity and regulatory compliance across QC systems, including LIMS, SAP Quality Management, and eQMS. You will act as a SME, drive data governance, and collaborate with Quality, Manufacturing, Regulatory Affairs, IT, and Supply Chain to enable reliable data-driven decisions.

You will lead data integrity initiatives, maintain data standards, support audits, and contribute to system validation and upgrades while aligning with FDA 21 CFR Part 11 and