Analyst IV, Dossier Data Integrity, Quality Control Operations

We are seeking a dedicated Analyst IV, Dossier Data Integrity to join our Quality Control Operations team as a contractor. This individual will play a key role in ensuring the completeness, accuracy, and traceability of regulatory filings and laboratory data . The role offers remote flexibility with occasional travel to our MA sites and potential visits to CMO/CTL locations.

Key Responsibilities:

• Data Integrity & Compliance: Verify the accuracy, consistency, and traceability of regulatory dossier sections against source methods and reports.
• Laboratory Data Review: Analyze and confirm the correctness of laboratory notebooks, worksheets, logbooks, and electronic records, ensuring compliance with GMP standards.
• Method Validation: Review complex documentation related to analytical method validation, verification, and transfer.
• Audit Trail...