QC Lab Operations Specialist

Qc Lab Operations Specialist

Regeneron is currently looking for a QC (Quality Control) Lab Operations Specialist. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. This position develops strategic plans related to change controls, maintains compliance records, and document workflows. They're responsible for supporting Quality Control laboratories with change control, investigations, method changes and document workflows.

As a QC Lab Operations Specialist, a typical day might include the following:

• Assess sophisticated change controls to evaluate if proposal satisfies company standards
• Review, edit, and revise controlled documentation in accordance with cGMP standards
• Ensures that all activities related to the investigation and resolutions of non-conformities are performed in a timely manner and in compliance with Regeneron procedures and regulatory requirements.
• Coordinate and/or lead cross-functional meetings with multiple departments to drive change control implementation
• Provide advice and mentorship to cross-functional teams to enable successful and GMP compliant change controls
• Independently monitor and progress multiple projects concurrently – identifying, addressing, and/or raising potential obstacles in a timely manner
• Present business critical and regulatory impactful change controls to senior leadership
• Document all training
• Assist with the training of new employees
• Collaborates with internal and external teams to harmonize operations and ensure consistency within quality control laboratories.
• Serves as Subject Matter Expert (SME) for laboratory operations.

This role might be for you if you :

• Have strong technical writing and interpersonal communication skills.
• Can manage multiple assignments and changing priorities through robust organizational, planning, and project management skills.
• Can work independently or part of a cross-functional team.
• Have experience navigating a controlled quality system.

To be considered for the QC Lab Operations Specialist you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a BS/BA in life sciences or equivalent combination of education and experience. For various levels you must have the following:

• Assoc QC Lab Operations Specialist: Requires a BS/BA in a scientific field or equivalent combination of education and experience
• QC Lab Operations Specialist: 2+ years of related experience or equivalent combination of education and experience.
• Sr QC Lab Operations Specialist: 5+ years of related experience or equivalent combination of education and experience.

Level is determined based on qualifications relevant to the role.