Senior Scientist Material Management & Qualification - Quality Control
Core
Subject matter expert for raw material qualification and release in a GMP-regulated manufacturing environment, ensuring material integrity and regulatory compliance.
Role type
Senior Scientist, Quality Control (Material Management)
Builds
GMP-compliant raw material supply chain for pharmaceutical/biopharmaceutical manufacturing
Domain
Pharmaceutical/Biopharmaceutical Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
raw material qualification, GMP compliance, OOS/OOT investigation, change control, deviation management, risk assessment, audit support, digital quality systems (SAP, TrackWise, LIMS), documentation authoring
Preferred skills
continuous improvement, gap assessment, remediation planning, cross-functional collaboration, digitalization of QC processes
Technologies
SAP, TrackWise, LIMS
Responsibilities
Lead and execute material disposition activities; Author, review, and maintain GMP-relevant documentation; Support OOS/OOT investigations and change control; Conduct gap assessments and define remediation measures; Act as SME during internal audits, customer audits, and regulatory inspections; Drive efficiency improvements in quality systems
Seniority
Senior, hands-on IC
