Overview
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.
Responsibilities
- 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.
Qualifications
- 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.
About Stratacuity
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. If you require an accommodation in using our website for a search or application, please contact us.
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