Compliance Data Specialist - GMP Investigations

Compliance Data Specialist - GMP Investigations

10 Oct 2025
New Jersey, Rensselaer 00000 Rensselaer USA

Compliance Data Specialist - GMP Investigations

Lead the collection, manipulation, and analysis of compliance-related data to support GMP investigations and continuous improvement initiatives.Assist with internal auditsDevelop and maintain Power BI dashboards and visualizations to communicate compliance trends, metrics, and investigation outcomes to stakeholders.Collaborate with cross-functional teams to identify root causes of non-conformances and recommend corrective and preventive actions (CAPAs).Support the preparation of investigation reports for medium to high-severity events, ensuring clarity, accuracy, and alignment with regulatory expectations.Monitor production and quality systems to gather data that informs investigation findings and compliance trends.Assist in the review and revision of controlled documents (e.g., SOPs, batch records, logbooks) to ensure alignment with cGMP standards.Participate in cross-functional meetings to present findings and drive resolution of compliance issues.Contribute to the development of quality metrics and KPIs that align with site and client goals.

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