Analyst IV, Dossier Data Integrity, Quality Control Operations

Cambridge, Massachusetts, United States - Remote

Full Time Contract Senior-level / Expert USD 83K - 155K *

BioPharma Consulting JAD Group

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Posted 1 day ago

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:

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.