What are the responsibilities and job description for the ANALYST IV, DOSSIER DATA INTEGRITY, QUALITY CONTROL OPERATIONS position at BioPharma Consulting JAD Group?
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 Review : Evaluate audit trails to confirm data integrity and adherence to procedures.
- Collaborative Issue Resolution : Communicate with clients to address and resolve discrepancies in analytical data or reports.
- Process Improvement : Provide feedback and suggest process improvements for more efficient data review practices.
- SOP Adherence : Ensure all activities align with established SOPs and GMP requirements.
Requirements
Qualifications :
