QC External Testing Liaison & Operations Lead

Regeneron Pharmaceuticals, Inc.; City of Rensselaer (NY); On-site; USD 35,000 - 54,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a QC External Lab Coordinator to manage liaison with external testing labs and internal teams. You will oversee project timelines, issue resolution, and data integrity across QC, QA, Regulatory, Manufacturing, and Supply Chain.

The role emphasizes cGMP compliance, documentation, process improvements, and CAPA initiation while ensuring timely shipment of samples and data exchange with CTLs.

Qualifications

• Bachelor's degree in a scientific field (Biology, Chemistry, Microbiology, or related).
• 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.

Responsibilities

• Serve as the primary operational liaison between Contract Testing Laboratories (CTLs) and internal partners (QC, QA, Regulatory Affairs, Manufacturing, Supply Chain).
• Lead cross-functional meetings with CTLs and internal partners to establish project timelines, discuss issues, supervise progress, and drive resolution.
• Monitor CTL performance metrics, turnaround times, testing capacity, and schedule adherence; identify risks and implement mitigations.
• Use a LIMS sample tracking system to review inventory against samples sent/received by external labs to ensure 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 of test data.
• Provide technical support for invalid assays, deviations, and OOS/OOT investigations.

Education

Bachelor's degree in a scientific field (Biology, Chemistry, Microbiology, or related)

Job description

Regeneron Pharmaceuticals, Inc. is seeking a QC External Lab Coordinator to manage liaison with external testing labs and internal teams. You will oversee project timelines, issue resolution, and data integrity across QC, QA, Regulatory, Manufacturing, and Supply Chain.

The role emphasizes cGMP compliance, documentation, process improvements, and CAPA initiation while ensuring timely shipment of samples and data exchange with CTLs.