Data Integrity Specialist
Role Overview: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.Responsibilities: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.Qualifications:Bachelor's degree in a scientific, engineering, quality, or related discipline.Experience within 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, TrackWise, LabVantage, or similar systems preferred.Strong attention to detail and ability to identify documentation inconsistencies and compliance risks.Excellent written and verbal communication skills.