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.
Qualifications:
- Education: B.S. in Chemistry, Biology, Biochemistry, or a related field.
- Experience: 5+ years in GMP Quality Control within the Pharmaceutical/Biotech industry, with increasing responsibilities.
- Technical Expertise: Proficiency in method transfer, analytical method lifecycle management, and phase-appropriate approaches.
- Technical Writing: Strong technical writing skills, especially for investigations and reports.
- Analytical Skills: Solid problem-solving abilities and experience with CAPA implementation.
- Software Proficiency: Familiarity with LabWare LIMS, Microsoft Excel, Word, and PowerPoint.
- Soft Skills: Excellent organizational, communication, and teamwork abilities.
