Senior Quality Control Consultant – Analytical Reference …, Boston

Senior Quality Control Consultant – Analytical Reference Standard Program Development

Lead the development and oversight of a Reference Standard Program to support analytical testing for product release and stability.

• Develop and manage reference standard inventory, qualification, and lifecycle tracking.
• Author SOPs and protocols aligned with ICH, FDA, EMA, GMP/GLP standards.
• Plan and execute qualification and requalification strategies for standards and assay controls.
• Monitor performance trends using statistical tools such as JMP or Minitab.
• Coordinate testing activities and communicate with contract labs and internal teams.
• Assign values to reference standards using validated methods, perform statistical analysis, and maintain thorough documentation of qualification studies and results.

• BS/MS in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• 5+ years in QC or analytical development within biopharma.
• Proficient in statistical analysis and trending software.
• Strong understanding of global regulatory guidelines and compliance.
• Skilled in technical writing and cross-functional communication.

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