QC External Lab Coordinator

Role Summary

Regeneron is seeking a Quality Control External Lab Coordinator responsible for sample management, test monitoring, and deviation management at external laboratories supporting QC operations across multiple areas 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 the external laboratories to determine accuracy and to maintain sample integrity.
• Coordinating the external laboratories and Regeneron subject matter experts (SMEs) in troubleshooting and identifying root cause analysis.
• Documenting, detailing and presenting discrepancies to appropriate personnel in a timely and efficient manner.
• Ensuring that all work performed is in compliance with the required regulatory standards (e.g., cGMP), conforms to company policies and standard operating procedures (SOPs).
• Proactively identifying and implementing process improvements.
• Additional responsibilities aligned with the role as required.

Qualifications

• To be considered, you must be willing and able to work 1st shift, Monday-Friday, 8:00am-4:30pm, with occasional off-shift work including holidays or weekends.
• BS/BA in Life Sciences or related field, or equivalent combination of education and experience.
• Experience levels based on role: QC External Lab Coordinator I: 0-2 years; II: 2+ years; III: 4+ years. Level is determined based on qualifications relevant to the role.

Skills

• Outstanding interpersonal skills and ability to convey ideas and address issues with peers and management.
• Strong written and verbal communication abilities.
• Strong accuracy and thoroughness in task execution.
• Ability to adapt to changing priorities, manage multiple responsibilities, and meet deadlines.
• Strong organizational skills and data management abilities.
• Excellent time management and a drive for continuous improvement.

Education

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