Senior Associate Scientist, External Quality Analytical Oversight
Core
Review external QC laboratory data for commercial release and stability testing, ensuring global cGMP compliance across the commercial manufacturing network.
Role type
Senior Associate Scientist (External Quality Analytical Oversight)
Builds
Commercial manufacturing network QC deliverables
Domain
Biopharmaceuticals / Quality Control
Required skills
Commercial Quality Control, analytical development, GMP principles, data integrity, LIMS, electronic documentation management, SAP specification authoring, OOS/OOT/OOE investigation, CAPA, SOP authoring
Preferred skills
Contract laboratory management, continuous improvement, cross-functional collaboration
Technologies
LIMS, SAP, electronic documentation management system
Responsibilities
Review external QC laboratory data for commercial release and stability testing; verify method conditions, sample preparation, and calculation accuracy in raw data packages; use LIMS to authorize results and generate reports; resolve data discrepancies and track corrections; compile QC metrics and maintain batch release trackers; contribute to continuous improvement of data review processes and electronic workflows.
Seniority
Senior, hands-on IC
