QC External Lab Coordinator — Cross-Functional Lab Ops

Regeneron Pharmaceuticals, Inc (USA); United States; Presencial; USD 35.000 - 54.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc (USA) seeks a QC External Lab Coordinator to manage external testing activities and ensure cGMP compliance. The role interfaces with CTLs, QC, QA, Regulatory, and Supply Chain to drive timelines, data integrity, and issue resolution.

The position requires a scientific degree and familiarity with cGMP; occasional on-call support and on-site work in Rensselaer, NY, with a Monday–Friday schedule on the 1st shift.

Formación

• Bachelor's degree in a scientific field (Biology, Chemistry, Microbiology, or related field).
• Experience with cGMP is preferred.
• Occasions where you may be on call during off-hours to support critical shipment or entry of results.
• Level is settled based on qualifications relevant to the role.

Responsabilidades

• Serve as primary operational liaison between CTLs and internal partners (QC, QA, Regulatory Affairs, Manufacturing, Supply Chain).
• Lead cross-functional meetings with CTLs and internal partners to set timelines, discuss issues, supervise progress and drive resolution.
• Monitor CTL performance metrics, turnaround times, testing capacity, and schedule adherence; identify risks and mitigate.
• Use a LIMS to review sample inventory against samples sent/received to maintain accuracy and sample integrity.
• Coordinate activities between external laboratories and Regeneron SMEs to troubleshoot issues and identify root causes.
• Coordinate on-time shipment of samples to Contract Testing Labs and receipt/entry of test data.
• Provide technical support for invalid assays, deviations, OOS/OOT investigations.
• Initiate and complete CAPAs and Change Controls per site procedures and write/update SOPs as needed.

Conocimientos

Bachelor's degree

On-call readiness

cGMP awareness

Educación

Bachelor's degree in scientific field

Herramientas

LIMS

Descripción del empleo

Regeneron Pharmaceuticals, Inc (USA) seeks a QC External Lab Coordinator to manage external testing activities and ensure cGMP compliance. The role interfaces with CTLs, QC, QA, Regulatory, and Supply Chain to drive timelines, data integrity, and issue resolution.

The position requires a scientific degree and familiarity with cGMP; occasional on-call support and on-site work in Rensselaer, NY, with a Monday–Friday schedule on the 1st shift.