Demo

Analyst IV, Dossier Data Integrity, Quality Control Operations

BioPharma Consulting JAD Group
Cambridge, MA Contractor
POSTED ON 2/17/2025
AVAILABLE BEFORE 8/12/2025
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

If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution. Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right. Surveys & Data Sets

What is the career path for a Analyst IV, Dossier Data Integrity, Quality Control Operations?

Sign up to receive alerts about other jobs on the Analyst IV, Dossier Data Integrity, Quality Control Operations career path by checking the boxes next to the positions that interest you.
Income Estimation: 
$59,426 - $77,437
Income Estimation: 
$67,174 - $85,435
Income Estimation: 
$101,850 - $147,372
Income Estimation: 
$111,881 - $143,704
Income Estimation: 
$95,921 - $146,578
Income Estimation: 
$133,838 - $172,011
Income Estimation: 
$136,751 - $179,120
Income Estimation: 
$74,048 - $101,143
Income Estimation: 
$101,850 - $147,372
Income Estimation: 
$82,394 - $101,811
Income Estimation: 
$86,266 - $138,642
Income Estimation: 
$128,588 - $163,256
Income Estimation: 
$80,927 - $120,007
Income Estimation: 
$103,989 - $160,643
View Core, Job Family, and Industry Job Skills and Competency Data for more than 15,000 Job Titles Skills Library

Job openings at BioPharma Consulting JAD Group

BioPharma Consulting JAD Group
Hired Organization Address Norton, MA Contractor
The Quality Control Operations (QCO) Analyst III Contractor plays a crucial role in ensuring quality and compliance acro...
BioPharma Consulting JAD Group
Hired Organization Address Cambridge, MA Contractor
The Accounting Contractor will play a vital role in ensuring timely and accurate financial reporting. This position invo...
BioPharma Consulting JAD Group
Hired Organization Address Cambridge, MA Contractor
Consultant Reporting and Analytics Global Safety Systems (GSS) will work with different stakeholders to generate the dat...
BioPharma Consulting JAD Group
Hired Organization Address Norton, MA Contractor
This position within the Manufacturing Technical Services (MTS) group will support regulatory dossier content and proces...

Not the job you're looking for? Here are some other Analyst IV, Dossier Data Integrity, Quality Control Operations jobs in the Cambridge, MA area that may be a better fit.

Dossier Quality Control

Dexian, Cambridge, MA

AI Assistant is available now!

Feel free to start your new journey!