QC External Lab Coordinator – Testing & Compliance

Regulatory Jobs; City of Rensselaer (NY); On-site; USD 34,000 - 54,000; Full time

Benefits offered by this job

Health and wellness programs

Stock for employees

Job summary

Regeneron is seeking a QC External Lab Coordinator in Rensselaer, NY. You will serve as the operational liaison between Contract Testing Laboratories and internal teams, leading cross-functional meetings, tracking performance, and ensuring sample integrity via LIMS.

The role requires a scientific bachelor's degree and familiarity with cGMP; some on-call duties may be needed. Work is on-site with a typical 1st shift schedule, 8:00am-4:30pm, Monday to Friday.

Qualifications

• Bachelor's degree in a scientific field such as Biology, Chemistry, Microbiology, or related field.
• Experience with cGMP regulations is preferred.
• Ability to work on-call during off-hours may be required.

Responsibilities

• Serve as the primary liaison between CTLs and internal Regeneron partners.
• Lead cross-functional meetings to set timelines, discuss issues, and drive resolution.
• Monitor CTL performance metrics and coordinate mitigation plans.
• Review sample inventory in the LIMS and ensure sample integrity.
• Coordinate with SMEs to troubleshoot issues and identify root causes.
• Arrange on-time shipment of samples to contract labs and manage data entry.
• Provide technical support for invalid assays, deviations, OOS/OOT investigations.
• Initiate CAPAs and Change Controls per site procedures.
• Write and update SOPs and manage workflows in the document system.
• Ensure compliance with regulatory requirements and company SOPs.
• Identify and implement process improvements and lean initiatives.

Skills

cGMP knowledge

Education

Bachelor's degree in a scientific field

Job description

Regeneron is seeking a QC External Lab Coordinator in Rensselaer, NY. You will serve as the operational liaison between Contract Testing Laboratories and internal teams, leading cross-functional meetings, tracking performance, and ensuring sample integrity via LIMS.

The role requires a scientific bachelor's degree and familiarity with cGMP; some on-call duties may be needed. Work is on-site with a typical 1st shift schedule, 8:00am-4:30pm, Monday to Friday.