QC External Lab Coordinator

Regeneron Pharmaceuticals • Rensselaer, NY

1d • $21 - $44 • Onsite

About The Position

Regeneron is currently looking for a Quality Control (QC) External Coordinator. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. This position is responsible for sample management, test monitoring, and deviation management activities at external laboratories supporting a wide variety of QC operational areas including raw materials, virology, analytical, microbiological, and analytical testing. Our QC External Lab Coordinators support daily operations in accordance with Standard Operating Procedures (SOPs) in a cGMP regulatory environment. As a QC External Lab Coordinator, a typical day might include the following: 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 (ex. cGMP), conforms to company policies and standard operating procedures (SOPs). Proactively identifying and implementing process improvements. Additional responsibilities aligned with the role as required.

Requirements

• Demonstrate outstanding interpersonal skills, effectively conveying ideas and addressing issues with both peers and management.
• Exhibit strong written and verbal communication abilities.
• Excel in ensuring accuracy and thoroughness in task execution.
• Adapt seamlessly to changing priorities, manage multiple responsibilities, and consistently meet deadlines.
• Possess strong organizational skills, with the ability to manage and maintain data or information efficiently.
• Display excellent time management capabilities to optimize productivity.
• Thrive in continuous improvement initiatives, actively seeking opportunities to enhance processes and drive better performance.
• Be willing and able 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

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 (ex. cGMP), conforms to company policies and standard operating procedures (SOPs).
• Proactively identifying and implementing process improvements.
• Additional responsibilities aligned with the role as required.

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level