QC External Lab Liaison & Testing Operations Lead

Regeneron Pharmaceuticals, Inc.; United States; Presencial; USD 70.000 - 100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health and wellness programs

Fitness centers

Stock for employees at all levels

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. is seeking a QC External Lab Coordinator to coordinate external testing activities and ensure cGMP compliance.

The role acts as the main liaison between CTLs and internal partners, driving timelines, issue resolution, and data integrity through LIMS and SOPs. The successful candidate will oversee performance metrics, CAPAs, and change controls, while supporting on-time shipment and data receipt from external labs.

Formación

• Bachelor's degree in a scientific field (Biology, Chemistry, Microbiology, or related field).
• Experience with cGMP is preferred.
• Occasions where you may be required to be on call during off-hours (weekends/holidays).

Responsabilidades

• Serve as the primary operational liaison between Contract Testing Laboratories (CTLs) and internal partners, including QC, QA, Regulatory Affairs, Manufacturing, and Supply Chain teams.
• Lead cross-functional meetings with CTLs and internal partners to establish project timelines, discuss technical issues, supervise progress, and drive issue resolution.
• Monitor CTL performance metrics, turnaround times, testing capacity, and schedule adherence; grow risks and implement mitigation plans as appropriate.
• Use a sample tracking system (LIMS) to review sample inventory against samples sent and received by external laboratories to resolve accuracy and maintain 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.
• Coordinate receipt and entry of test data from Contract Testing Labs.
• Provide technical support for invalid assays, deviations, OOS/OOT investigations.
• Initiate and complete CAPAs and Change Controls in accordance with site procedures.
• Write new SOPs and update existing SOPs as needed.
• Initiate and handle workflows in the electronic document management system.
• Ensure all work follows regulatory requirements (e.g., cGMP), SOPs, and company policies.
• Proactively identify and implement process improvements and lean initiatives.
• Perform other duties relevant to the position as required.

Conocimientos

Project coordination

Cross-functional collaboration

Regulatory compliance

GMP knowledge

LIMS

Educación

Bachelor's degree in a scientific field

Herramientas

LIMS

Descripción del empleo

Regeneron Pharmaceuticals, Inc. is seeking a QC External Lab Coordinator to coordinate external testing activities and ensure cGMP compliance.

The role acts as the main liaison between CTLs and internal partners, driving timelines, issue resolution, and data integrity through LIMS and SOPs. The successful candidate will oversee performance metrics, CAPAs, and change controls, while supporting on-time shipment and data receipt from external labs.