QC External Lab Testing Coordinator

Regeneron Pharmaceuticals, Inc.; New York (NY); On-site; USD 34,000 - 54,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a QC External Lab Coordinator to support the daily operations of the QC External Testing group in compliance with SOPs and cGMP.

The role focuses on liaison work between external testing labs and internal partners, driving timelines and issue resolution while ensuring data integrity and regulatory alignment. The position involves coordinating sample shipments, data receipt, CAPA/Change Controls, and SOP updates, with on-site responsibilities at the

Qualifications

• Bachelor's degree in a scientific field (Biology, Chemistry, Microbiology, or related).
• Experience with cGMP is preferred.
• On-call during off-hours may be required to support critical shipments or result entry.

Responsibilities

• Serve as the primary liaison between CTLs and internal partners (QC, QA, Regulatory, Manufacturing, Supply Chain).
• Lead cross-functional meetings to set timelines, discuss issues, supervise progress and drive resolution.
• Monitor CTL performance metrics, turnaround times, capacity and adherence; implement mitigations.
• Review sample inventory in LIMS and ensure sample integrity and accuracy.
• Coordinate with Regeneron SMEs to troubleshoot issues and identify root causes.
• Coordinate shipment of samples to CTLs and receipt of test data.
• Provide technical support for invalid assays, deviations, OOS/OOT investigations.
• Initiate CAPAs and Change Controls; write/update SOPs; manage workflows in the EDMS.

Skills

cGMP experience

Education

Bachelor's degree in a scientific field

Job description

Regeneron Pharmaceuticals, Inc. is seeking a QC External Lab Coordinator to support the daily operations of the QC External Testing group in compliance with SOPs and cGMP.

The role focuses on liaison work between external testing labs and internal partners, driving timelines and issue resolution while ensuring data integrity and regulatory alignment. The position involves coordinating sample shipments, data receipt, CAPA/Change Controls, and SOP updates, with on-site responsibilities at the