QC External Lab Coordinator

Regeneron Pharmaceuticals•Rensselaer, NY

3d•$25 - $39•Onsite

About The Position

Regeneron is seeking a Quality Control (QC) External Lab Coordinator to support the daily operations of the QC External Testing group in accordance with Standard Operating Procedures (SOPs) and cGMP regulations. The role serves as the primary operational liaison between Contract Testing Laboratories (CTLs) and internal partners, including QC, QA, Regulatory Affairs, Manufacturing, and Supply Chain teams. The position is based in Rensselaer, New York, and is scheduled for first shift, Monday through Friday, from 8:00 a.m. to 4:30 p.m. The role may require being on call during off-hours, including weekends and holiday breaks, to support critical shipments or results entry. Position level will be determined based on qualifications relevant to the role.

Requirements

Bachelor's degree in a scientific field such as Biology, Chemistry, Microbiology, or a related field.
May be required to be on call during off-hours, including weekends and holiday breaks, to support critical shipments or results entry.

Nice To Haves

Experience with cGMP.

Responsibilities

Serve as the primary operational liaison between Contract Testing Laboratories and internal QC, QA, Regulatory Affairs, Manufacturing, and Supply Chain partners.
Lead cross-functional meetings with CTLs and internal partners to establish project timelines, discuss technical issues, supervise progress, and drive issue resolution.
Monitor CTL performance metrics, turnaround times, testing capacity, and schedule adherence; identify growing risks and implement mitigation plans as appropriate.
Use LIMS to review sample inventory against samples sent to and received from external laboratories, resolve accuracy issues, and maintain sample integrity.
Coordinate activities between external laboratories and Regeneron subject matter experts to troubleshoot issues and identify root causes.
Coordinate the on-time shipment of samples to Contract Testing Laboratories.
Coordinate receipt and entry of test data from Contract Testing Laboratories.
Provide technical support for invalid assays, deviations, and OOS/OOT investigations as needed.
Initiate and complete CAPAs and Change Controls in accordance with site procedures.
Write new SOPs and update existing SOPs as needed.
Initiate and handle workflows in the electronic document management system.
Ensure work complies with regulatory requirements, company policies, and SOPs.
Identify and implement process improvements and lean initiatives.
Perform other duties relevant to the position as required.

Benefits

Health and wellness programs
Fitness centers
Stock for employees at all levels
Annual bonuses or other incentive plans may be offered depending on country and role.
Equity awards may be offered depending on country and role.
Pension or retirement benefits may be offered depending on country and role.
401(k) company match may be offered depending on country and role.
Insurance benefits, including medical, dental, vision, life, and disability, may be offered depending on country and role.
Paid time off may be offered depending on country and role.
Family support benefits may be offered depending on country and role.