Sr Associate Quality Control I
Core
Lead QC Chemistry lab startup, perform qualification/routine testing, and support manufacturing operations for biopharmaceutical medicines.
Role type
Senior IC Quality Control Associate (Chemistry)
Builds
Qualified and validated chemistry laboratory systems and testing methods for biopharmaceutical production
Domain
Biopharmaceuticals / GMP Manufacturing
Required skills
GMP compliance, laboratory techniques, equipment validation, method transfer, document authoring (SOPs), deviation/CAPA/change control management, LIMS proficiency
Preferred skills
Chemistry/Biochemistry degree, analytical testing experience, regulatory knowledge, technical writing, team collaboration
Technologies
LIMS, LMES/CIMS, HPLC, UPLC, TOC
Responsibilities
Lead QC Chemistry startup activities including system qualification and validation; Author, revise, and review documents including SOPs and technical reports; Manage Deviation, CAPA, and Change Control records; Support routine testing and weekend/shift work as required
Seniority
Senior, hands-on IC
