Data Integrity Specialist

Job Description

Job Responsibilities:

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• Perform data integrity reviews across computerized systems, equipment, and supporting documentation.

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• Examine audit trails and electronic records for unusual activity, unauthorized changes, missing information, or potential data manipulation.

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• Review SOPs, user documentation, validation records, and other controlled documents for compliance and completeness.

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• Assess data for accuracy, consistency, traceability, and overall reliability.

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• Evaluate system access, user permissions, and controls surrounding electronic records.

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• Review backup, recovery, and record-retention practices where applicable.

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• Identify gaps between current processes and applicable regulatory or company requirements.

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• Help determine the potential risk associated with compliance findings and recommend appropriate corrective actions.

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• Partner with Quality, IT, laboratory, manufacturing, and other technical teams to investigate and resolve data-related issues.

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• Prepare clear documentation of assessments, observations, risks, and recommended improvements.

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• Support periodic reviews of equipment, systems, and processes to maintain an ongoing state of compliance.

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• Stay current on evolving data integrity expectations and applicable FDA, GMP, GLP, and international regulatory requirements.

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Qualifications:

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• Bachelor's degree in a scientific, technical, quality, or related field preferred; equivalent experience will be considered.

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• 3+ years of experience working in a regulated pharmaceutical, biotechnology, medical device, laboratory, or manufacturing environment.

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• Working knowledge of GMP, GLP, GCP, or other regulated quality environments.

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• Experience reviewing or creating SOPs, work instructions, technical documentation, or quality records.

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• Understanding of data integrity principles, electronic records, audit trails, and controlled access.

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• Strong analytical and investigative skills with the ability to identify inconsistencies and determine potential root causes.

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• Comfortable working with Microsoft Office applications, including Word and Excel; experience with SharePoint or project-management tools is a plus.

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• Strong written and verbal communication skills with the ability to clearly document findings and communicate with both technical and non-technical stakeholders.

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