Analyst IV - Dossier Data Integrity, Quality Control Operations

Overview:
The Analyst IV – Dossier Data Integrity, Quality Control Operations ensures the integrity, completeness, and accuracy of regulatory filings, laboratory data, and reports to maintain the highest standards of quality and compliance. This role supports commercialization efforts through meticulous review and verification of data, ensuring alignment with Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP).

Key Responsibilities:

• Verify the integrity and traceability of regulatory dossier sections by reviewing them against reference methods and reports.
• Review analytical data to ensure accuracy, correct transcription, and completeness of associated references.
• Audit laboratory notebooks, worksheets, logbooks, and electronic data for compliance and accuracy.
• Ensure adherence to approved protocols during analytical method validation, verification, and transfer...