Sr Associate Product Quality - Analytical
Core
Individual contributor supporting Product Quality Teams for late-stage clinical and commercial products by authoring regulatory reports and managing GMP data.
Role type
Sr Associate Product Quality - Analytical
Builds
Technical and regulatory reports for global submissions
Domain
Pharmaceutical/Biotechnology Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, Chromatographic techniques/software, Veeva, Empower, LIMS, Spotfire, data management, analytical skills, problem-solving
Preferred skills
stability data management, annual product review assembly, business process improvement, electronic data tool development
Technologies
Veeva, Empower, LIMS, Spotfire, MS Office
Responsibilities
Navigate and execute transactions in GMP systems, Author and maintain GMP technical reports, Collate, review, verify, and archive GMP data, Ensure accuracy and completeness of product data, Collaborate across global teams, Drive standardization of data and chromatographic overlay activities
Seniority
Senior, hands-on IC
