Specialist, QC Sample Management
Core
Manage the processing, storage, and delivery of Drug Substance, Drug Product, and Raw Material samples to support QC testing and stability studies.
Role type
Specialist, QC Sample Management
Builds
Sample logistics and stability study support for Global Biologics Laboratory and Multi Product Cell Culture Facility
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, hands-on operational role