Data Integrity Specialist

Harba Solutions Inc.; St. Louis (MO); On-site; USD 60,000 - 80,000; Full time

Job summary

Harba Solutions Inc. is seeking a Data Integrity Specialist to ensure data accuracy and compliance in a fast-paced, regulated manufacturing environment in St. Louis, Missouri. The role encompasses reviewing documentation, supporting investigations, and collaborating with various teams to enhance quality systems.

The ideal candidate will hold a relevant degree and have experience in GMP environments, with strong attention to detail and excellent communication skills.

Qualifications

• Experience within pharmaceutical, biotechnology, or regulated manufacturing environments.
• Working knowledge of GMP, GxP, and good documentation practices.
• Ability to identify documentation inconsistencies and compliance risks.

Responsibilities

• Review laboratory and manufacturing documentation for compliance.
• Support data integrity assessments and remediation activities.
• Investigate documentation discrepancies and data-related quality events.
• Assist with root cause investigations and corrective actions.
• Support audit readiness activities and participate in inspections.

Skills

Attention to detail

Verbal communication

Documentation practices

Investigation support

Education

Bachelor's degree in a scientific, engineering, quality, or related discipline

Tools

LIMS

QMS

EDMS

TrackWise

LabVantage

Job description

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.