Remote Quality Analyst IV-Data Integrity

Advantage Technical - Cambridge, MA

Full-time - Mid Level

Remote - Cambridge, MA

1,001-5,000 employees

Administrative and Support Services

About the position

The Analyst IV Dossier Data Integrity in Quality Control Operations is a contractor role focused on ensuring high standards of quality and compliance in the commercialization of company programs. This position involves verifying the completeness, consistency, and accuracy of regulatory filings and laboratory data, ensuring adherence to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP).

Responsibilities

• Verify the integrity and traceability of regulatory dossier sections.
• Review regulatory dossier sections against associated reference methods and reports for accuracy in data reporting/transcription.
• Review analytical data for accuracy in data reporting/transcription and for complete and correct entries of all associated references.
• Verify the integrity and traceability of all data generated and reported.
• Review data documented by laboratory personnel within laboratory notebooks, worksheets, and logbooks.
• Review complex notebooks involving analytical method validation, verification, and transfer testing.
• Review audit trail to ensure that electronic data were generated according to applicable procedures.
• Ensure that all affiliated data including electronic data and respective notebooks/logbooks are complete and reviewed.
• Discuss with clients to resolve all required corrections to analytical data or reports.
• Work in accordance with Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP).
• Consult with management regarding priority of assignments and communicate any deviations/discrepancies noted during the review process.
• Provide feedback and suggest ideas to improve the review process.
• Perform any other duties as assigned by management.

Requirements

• B.S. in chemistry, biology, or biochemistry, or related scientific field.
• 5 years of experience in a GMP Quality Control function or equivalent relevant industry experience with demonstrated increase in responsibility.
• Experience in method transfer and/or analytical method implementation; solid understanding of method lifecycle management and phase-appropriate approach.
• Demonstrated technical writing skills, with preference for technical writing of investigations.
• Proficient in data analysis and interpretation, with excellent attention to detail to inform decision-making.
• Solid problem-solving skills and experience in conducting investigations and implementing CAPA.
• Strong organizational skills with the ability to manage multiple tasks simultaneously and autonomously.
• Excellent communication and teamwork abilities, capable of working effectively in a collaborative environment.
• Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred.