Quality Data Steward: LIMS/eQMS & Compliance Expert

Kelly Services; Raleigh (NC); On-site; USD 76,000 - 110,000; Full time

Job summary

Kelly Services in Raleigh, NC seeks a Quality Data Steward to ensure accuracy, integrity, and regulatory compliance of quality data across LIMS, SAP, and eQMS. The role enforces data governance, supports audits, and drives informed decisions in a regulated manufacturing environment.

You will collaborate cross-functionally with Quality, Manufacturing, IT, Regulatory Affairs, and Supply Chain; train users, monitor data quality, and participate in CSV activities and CAPAs.

Qualifications

• Bachelor's degree in a scientific, technical, or related field.
• Minimum of five (5) years of experience in a regulated industry.
• Experience with LIMS, SAP Quality Management, eQMS, or other electronic quality systems.
• Strong knowledge of cGMP, FDA regulations, 21 CFR Part 11, EU GMP Annex 11, and ALCOA+ data integrity principles.
• Experience supporting data governance, electronic data management, and quality systems.
• Excellent written and verbal communication skills.

Responsibilities

• Administer and maintain LIMS to ensure data accuracy, integrity, security, and regulatory compliance.
• Serve as the SME for LIMS by providing system support, troubleshooting, and issue resolution.
• Support SAP Quality Management functions, including master data, system enhancements, upgrades, and troubleshooting.
• Monitor data quality, investigate data anomalies, and implement corrective actions.
• Support implementation, validation, and maintenance of electronic quality systems and system upgrades.
• Author, review, and maintain SOPs, specifications, protocols, reports, and system documentation.
• Ensure compliance with cGMP, FDA regulations, 21 CFR Part 11, EU GMP Annex 11, ALCOA+, and internal quality systems.
• Support CSV activities, including change controls, risk assessments, testing, and validation documentation.
• Assist with internal audits, regulatory inspections, data integrity assessments, CAPAs, and remediation activities.
• Generate, analyze, and report laboratory and quality data to identify trends and support investigations.
• Support APRs, quality metrics, and management reporting.
• Train users on LIMS, SAP, electronic systems, and data management processes.
• Collaborate with Quality, Manufacturing, IT, Regulatory Affairs, and Supply Chain to resolve system and data-related issues.
• Perform additional duties and special projects as assigned.

Skills

Analytical skills

Troubleshooting

Organizational skills

Communication skills

Education

Bachelor's degree in a scientific, technical, or related field

Tools

LIMS

SAP Quality Management

eQMS

Excel

Job description

Kelly Services in Raleigh, NC seeks a Quality Data Steward to ensure accuracy, integrity, and regulatory compliance of quality data across LIMS, SAP, and eQMS. The role enforces data governance, supports audits, and drives informed decisions in a regulated manufacturing environment.

You will collaborate cross-functionally with Quality, Manufacturing, IT, Regulatory Affairs, and Supply Chain; train users, monitor data quality, and participate in CSV activities and CAPAs.