Specialist, QC Sample Management
Core
Manage the processing, delivery, storage, and release of Drug Substance, Drug Product, and Raw Material samples for QC testing and stability studies in a GMP-compliant pharmaceutical environment.
Role type
Specialist, QC Sample Management
Builds
Drug Substance, Drug Product, and Raw Material samples for QC testing and stability studies
Domain
Pharmaceutical manufacturing / Quality Control
Required skills
GMP compliance, LIMS/CIMS logging, sample reconciliation, SOP generation, aseptic manufacturing knowledge, buffer preparation, stability study support
Preferred skills
None stated
Technologies
LIMS, CIMS, TempTales
Responsibilities
Liaise with manufacturing and logistics to ensure timely sample delivery; Log samples to LIMS/CIMS and label accordingly; Release samples for QC testing; Store backups and reserve samples; Perform monthly reconciliation and report deviations; Reconstitute and aliquot samples for QC activities; Support buffer preparation and stability study enrolment; Generate and update SOPs; Maintain GMP compliance and training.
Seniority
Specialist, individual contributor
