Data Integrity Specialist

We are seeking a Data Integrity Specialist to support quality and compliance initiatives within a highly regulated manufacturing environment. This individual will play a key role in ensuring the accuracy, completeness, consistency, and traceability of data generated across laboratory, manufacturing, and quality systems. The ideal candidate will have experience working within GMP-regulated environments and possess a strong understanding of documentation practices, quality systems, investigations, and electronic records management.

• Review laboratory and manufacturing documentation to ensure compliance with internal procedures and regulatory requirements.
• Support data integrity assessments, documentation reviews, and remediation activities.
• Investigate documentation discrepancies, procedural deviations, and data-related quality events.
• Assist with root cause investigations, corrective actions (CAPAs), and effectiveness checks.
• Evaluate electronic and paper-based records for accuracy, completeness, and traceability.
• Support audit readiness activities and participate in internal and external inspections.
• Collaborate with Quality, Manufacturing, Laboratory Operations, Validation, and Technical Services teams.
• Review and support updates to SOPs, work instructions, forms, and controlled documentation.
• Assist with implementation and continuous improvement of data governance and quality systems processes.
• Support activities related to LIMS, quality management systems, and other regulated electronic systems.

• Bachelor's degree in a scientific, engineering, quality, or related discipline.
• Experience with in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Working knowledge of GMP, GxP, and good documentation practices.
• Experience supporting investigations, deviations, CAPAs, audits, or quality systems.
• Familiarity with LIMS, QMS, EDMS, Track Wise, Lab Vantage, or similar systems preferred.
• Strong attention to detail and ability to identify documentation inconsistencies and compliance risks.
• Excellent written and verbal communication skills.