Quality Data Steward (LIMS/eQMS) – Pharmaceutical Manufacturing
Location: Raleigh, NC
Schedule: Fully Onsite | Monday–Friday | Normal Business Hours
Salary: $76,000–$110,000
Position Summary
The Data Steward is responsible for ensuring the accuracy, integrity, security, and compliance of quality-related electronic data across regulated systems including LIMS, SAP, and eQMS. This role supports data governance by maintaining data standards, monitoring data quality, and ensuring compliance with FDA, cGMP, 21 CFR Part 11, EU GMP Annex 11, and ALCOA+ principles. Working cross-functionally with Quality, Manufacturing, IT, Regulatory Affairs, and Supply Chain, the Data Steward helps drive data integrity, regulatory compliance, and informed business decisions.
Key Responsibilities

• Administer and maintain LIMS to ensure data accuracy, integrity, security, and regulatory compliance.
  

• Serve as the subject matter expert (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 Computer System Validation (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 Annual Product Reviews (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.

Qualifications
Required

• Bachelor’s degree in a scientific, technical, or related field.
  

• Minimum of five (5) years of experience in the pharmaceutical, biotechnology, medical device, or other 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.
  

• Strong analytical, troubleshooting, organizational, and problem-solving skills.
  

• Excellent written and verbal communication skills.
  

• Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.

Preferred

• Experience with Computer System Validation (CSV) and change control.
  

• Experience supporting audits, regulatory inspections, CAPAs, investigations, and quality risk assessments.
  

• Familiarity with laboratory operations, analytical testing, and Quality Control environments.
  

• Experience with quality metrics, data analysis, and reporting.
  

• Lean Six Sigma, ASQ, or other quality certifications are a plus.

Work Environment

• Fully onsite position based in Raleigh, NC.
  

• Standard Monday–Friday business hours.
  

• Office-based role with regular interaction in laboratory and manufacturing environments.
  

• Frequent computer-based work involving electronic quality systems and data management.
  

• Must be able to wear appropriate PPE when entering laboratory or manufacturing areas.
  

• Occasional schedule flexibility may be required to support audits, system implementations, validation activities, or business needs.

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