QC External Lab Coordinator

Role Summary

Quality Control (QC) External Lab Coordinator responsible for sample management, test monitoring, and deviation management activities at external laboratories supporting QC operations in areas including raw materials, virology, analytical, microbiological, and analytical testing, 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 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 all work performed is in compliance with regulatory standards (e.g., cGMP) and conforms to company policies and SOPs.
• Proactively identifying and implementing process improvements.
• Additional responsibilities aligned with the role as required.

Qualifications

• To be considered, willingness and ability to work 1st shift, Monday-Friday, 8:00am-4:30pm; occasional off-shift work including holidays or weekends may be needed.
• BS/BA in Life Sciences or related field; or equivalent combination of education & experience.
• QC External Lab Coordinator I: 0-2 years of related experience
• QC External Lab Coordinator II: 2+ years of related experience
• QC External Lab Coordinator III: 4+ years of related experience

Skills

• Outstanding interpersonal skills with the ability to convey ideas and address issues with peers and management.
• Strong written and verbal communication abilities.
• Accuracy and thoroughness in task execution.
• Ability to adapt to changing priorities, manage multiple responsibilities, and meet deadlines.
• Strong organizational skills with systematic data/information management.
• Excellent time management to optimize productivity.
• Engagement in continuous improvement initiatives to enhance processes and performance.

Education

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