QC External Lab Coordinator

Role Summary

Quality Control (QC) External Coordinator responsible for sample management, test monitoring, and deviation management activities at external laboratories supporting QC operations in a cGMP environment.

Responsibilities

• Coordinating timely shipment of samples to Contract Testing Labs, and entry of test data from Contract Testing Labs.
• Using a sample tracking system (LIMS) to review sample inventory against samples sent and received by external laboratories to determine accuracy and maintain sample integrity.
• Coordinating external laboratories and Regeneron SMEs in troubleshooting and identifying root cause analysis.
• Documenting, detailing and presenting discrepancies to appropriate personnel in a timely and efficient manner.
• Ensuring all work performed complies with regulatory standards (e.g., cGMP) and adheres to company policies and SOPs.
• Proactively identifying and implementing process improvements.
• Additional responsibilities aligned with the role as required.

Qualifications

• BS/BA in Life Sciences or related field, or equivalent combination of education and experience.
• QC External Lab Coordinator I: 0-2 years of related experience; II: 2+ years; III: 4+ years (level determined by qualifications).

Skills

• Excellent interpersonal, written, and verbal communication abilities.
• Strong attention to accuracy and thoroughness in task execution.
• Ability to adapt to changing priorities, manage multiple responsibilities, and meet deadlines.
• Strong organizational skills and data management capabilities.
• Effective time management and continuous improvement mindset.

Education

• BS/BA in Life Sciences or related field, or equivalent combination of education & experience.

Additional Requirements

• On-site work requirements; willingness to work 1st shift, Monday-Friday, 8:00am-4:30pm, with occasional off-shift work including holidays or weekends.