Senior Quality Control Data Scientist

What you'll do

• Validate and reconcile instrument-to-LIMS data flows to ensure completeness, accuracy, and integrity of transferred data.
• Maintain and monitor statistically valid control limits and Review by Exception logic while triaging out-of-trend signals.
• Validate parsing and data-transformation configurations for new method onboardings, instrument qualifications, and software releases.
• Build and maintain dashboards and reports to translate QC data into actionable information for stakeholders.
• Apply multivariate analysis, trending, and anomaly detection tools to support performance-monitoring and technical investigations.
• Troubleshoot data-transfer discrepancies to distinguish between formatting artifacts and true signal-integrity issues.
• Support GxP data integrity by contributing to investigations, CAPAs, and inspection readiness.
• Use LLMs to accelerate drafting and coding while ensuring AI remains out of validated GxP data decisions.

What we're looking for

• BS/BA in Biochemistry, Chemistry, Biology, Data/Computational Science, or a related field.
• 6+ years of relevant analytical or QC data experience.
• PhD with 2+ years of relevant experience (preferred).
• Experience in the pharmaceutical or biotechnology industries (preferred).
• Proven understanding of analytical and bioassay variability and the statistical basis for control limits, trending, and Review by Exception.
• Proficiency in applied statistics and data analysis including multivariate methods (PCA/PLS), trending, and anomaly detection.
• Strong SQL and data-modeling skills (ETL, data cleansing, transformation) and programming in Python and/or R.
• Experience with specialized statistical software (e.g., JMP, Minitab, SIMCA, Discoverant, MATLAB) and visualization tools (Tableau, Spotfire, Power BI).