QC Lab Operations Specialist

Role Summary

QC Lab Operations Specialist at Regeneron. Focused on change controls, compliance, and documentation workflows to support Quality Control laboratories. Drives investigations, method changes, and cross-functional collaboration to ensure GMP compliance.

Responsibilities

• Assess change controls to ensure proposals satisfy company standards
• Review, edit, and revise controlled documentation in accordance with cGMP standards
• Ensure investigations and resolutions of non-conformities are timely and compliant with procedures and regulatory requirements
• Coordinate and/or lead cross-functional meetings to drive change control implementation
• Provide advice and mentorship to cross-functional teams for GMP compliant change controls
• Monitor and progress multiple projects concurrently, addressing potential obstacles
• Present business-critical and regulatory-impactful change controls to senior leadership
• Document all training and assist with training of new employees
• Collaborate with internal and external teams to harmonize operations and ensure consistency within quality control laboratories
• Serve as Subject Matter Expert for laboratory operations

Qualifications

• Required: BS/BA in life sciences or equivalent
• Assoc QC Lab Operations Specialist: BS/BA in scientific field or equivalent
• QC Lab Operations Specialist: 2+ years of related experience or equivalent
• Sr QC Lab Operations Specialist: 5+ years of related experience or equivalent

Skills

• Strong technical writing and interpersonal communication
• Project management and the ability to manage multiple assignments and changing priorities
• Ability to work independently or in a cross-functional team
• Experience navigating a controlled quality system

Education

• BS/BA in life sciences or equivalent required

Additional Requirements

• Willing and able to work Monday-Friday, 8am-4:30pm