Data Integrity Specialist

Harba Solutions Inc.; Indianapolis (IN); On-site; USD 70,000 - 110,000; Full time

Job summary

Harba Solutions Inc. is seeking a data integrity professional to perform reviews across computerized systems, documentation, and equipment to ensure regulatory compliance.

The role involves examining audit trails, validating records, and assessing data integrity across processes, with collaboration across Quality, IT, and manufacturing teams. The ideal candidate has 3+ years in regulated environments, strong analytical skills, and experience with SOPs, GMP/GLP/GCP, and data governance.

Qualifications

• Bachelor's degree in a scientific, technical, quality, or related field preferred; equivalent experience will be considered.
• 3+ years of experience in a regulated pharmaceutical, biotechnology, medical device, laboratory, or manufacturing environment.
• Working knowledge of GMP, GLP, GCP, or other regulated quality environments.
• Experience reviewing or creating SOPs, work instructions, technical documentation, or quality records.
• Understanding of data integrity principles, electronic records, audit trails, and controlled access.
• Strong analytical and investigative skills with the ability to identify inconsistencies and determine potential root causes.
• Comfortable working with Microsoft Office applications, including Word and Excel; SharePoint experience is a plus.
• Strong written and verbal communication skills with the ability to document findings clearly.

Responsibilities

• Perform data integrity reviews across computerized systems, equipment, and supporting documentation.
• Examine audit trails and electronic records for unusual activity, unauthorized changes, missing information, or potential data manipulation.
• Review SOPs, user documentation, validation records, and other controlled documents for compliance and completeness.
• Assess data for accuracy, consistency, traceability, and overall reliability.
• Evaluate system access, user permissions, and controls surrounding electronic records.
• Review backup, recovery, and record-retention practices where applicable.
• Identify gaps between current processes and applicable regulatory or company requirements.
• Help determine the potential risk associated with compliance findings and recommend corrective actions.
• Partner with Quality, IT, laboratory, manufacturing, and other teams to investigate data-related issues.
• Prepare documentation of assessments, observations, risks, and recommended improvements.
• Support periodic reviews of equipment, systems, and processes to maintain compliance.

Skills

Data integrity

Analytical skills

Investigative skills

Documentation

Written and verbal communication

SOPs and technical documentation

Audit trails

Education

Bachelor's degree in science/technical/quality

Tools

Word

Excel

SharePoint

Job description

• Perform data integrity reviews across computerized systems, equipment, and supporting documentation.
• Examine audit trails and electronic records for unusual activity, unauthorized changes, missing information, or potential data manipulation.
• Review SOPs, user documentation, validation records, and other controlled documents for compliance and completeness.
• Assess data for accuracy, consistency, traceability, and overall reliability.
• Evaluate system access, user permissions, and controls surrounding electronic records.
• Review backup, recovery, and record-retention practices where applicable.
• Identify gaps between current processes and applicable regulatory or company requirements.
• Help determine the potential risk associated with compliance findings and recommend appropriate corrective actions.
• Partner with Quality, IT, laboratory, manufacturing, and other technical teams to investigate and resolve data-related issues.
• Prepare clear documentation of assessments, observations, risks, and recommended improvements.
• Support periodic reviews of equipment, systems, and processes to maintain an ongoing state of compliance.
• Stay current on evolving data integrity expectations and applicable FDA, GMP, GLP, and international regulatory requirements.

Qualifications:

• Bachelor's degree in a scientific, technical, quality, or related field preferred; equivalent experience will be considered.
• 3+ years of experience working in a regulated pharmaceutical, biotechnology, medical device, laboratory, or manufacturing environment.
• Working knowledge of GMP, GLP, GCP, or other regulated quality environments.
• Experience reviewing or creating SOPs, work instructions, technical documentation, or quality records.
• Understanding of data integrity principles, electronic records, audit trails, and controlled access.
• Strong analytical and investigative skills with the ability to identify inconsistencies and determine potential root causes.
• Comfortable working with Microsoft Office applications, including Word and Excel; experience with SharePoint or project-management tools is a plus.
• Strong written and verbal communication skills with the ability to clearly document findings and communicate with both technical and non-technical stakeholders.