GMP Sample Logistics Specialist

Abzena; Bristol Township (Bucks County); Presencial; USD 52.000 - 76.000; Jornada completa

Descripción de la vacante

Abzena is seeking a QC Sample Management Specialist to coordinate end-to-end receipt, custody, storage, and disposition of GMP and non-GMP samples across analytical testing, stability programs, manufacturing, and external testing labs.

You will maintain traceability, ensure data integrity, and support deviation investigations while coordinating daily priorities with QC, Stability, Manufacturing, QA, and external partners to protect turnaround times.

Formación

• Must follow SOPs and maintain contemporaneous documentation.
• Familiar with chain of custody, sample IDs, inventory reconciliation.
• Proficient in Microsoft Excel, Outlook; able to learn LIMS/ERP/electronic QMS.

Responsabilidades

• Receive manufacturing, release, stability, in-process, and reference samples; verify information and documentation.
• Log and track custody changes, location, status, and final disposition.
• Maintain end-to-end traceability, sample segregation, and data integrity.
• Coordinate sample setdowns, labeling, staging, storage, and distribution to QC or stability groups.
• Maintain inventories of samples, references, critical reagents, and controlled materials.
• Monitor storage capacities and respond to temperature excursions or equipment issues.
• Coordinate shipments to contract labs, international shipments as needed, and document records.
• Support GMP compliance, deviations, investigations, and continuous improvement in sample handling.

Conocimientos

Attention to detail

Communication

Time management

Excel/Outlook proficiency

Educación

High school diploma or equivalent

Associate degree in a related discipline

Bachelor’s degree in a relevant field

Herramientas

LIMS

ERP systems

Electronic tracking systems

Descripción del empleo

Abzena is seeking a QC Sample Management Specialist to coordinate end-to-end receipt, custody, storage, and disposition of GMP and non-GMP samples across analytical testing, stability programs, manufacturing, and external testing labs.

You will maintain traceability, ensure data integrity, and support deviation investigations while coordinating daily priorities with QC, Stability, Manufacturing, QA, and external partners to protect turnaround times.