Automation-Driven QC Lab Operations Specialist

BioSpace; City of Saratoga Springs (NY); On-site; USD 62,000 - 131,000; Full time

Job summary

Regeneron is hiring multiple Quality Control (QC) Lab Operation Specialists for a new automated drug substance manufacturing facility in Saratoga Springs, NY. The role supports instrument troubleshooting, method launches, and data integrity in a GMP environment.

Initial location is Rensselaer, NY, with permanent posting in Saratoga Springs. Shifts vary by schedule, with 12-hour nights and day shifts depending on start date, requiring flexibility across schedules.

Qualifications

• BS/BA in Engineering, Chemistry, or Life Sciences required or equivalent.
• Experience with laboratory instrumentation in GMP environments preferred.
• Familiarity with ALCOA+ data integrity principles.

Responsibilities

• Serve as first point of contact for instrument, software, and workflow issues during testing.
• Support analysts during first executions of new methods and instruments.
• Troubleshoot QC instrumentation and coordinate service visits and documentation.
• Maintain instrument status, logbooks, and equipment records per site procedures.
• Assist in laboratory investigations and deviations, with data review and root cause analysis.

Skills

HPLC

GC

ALCOA+

FDA cGMP

Good Documentation Practices

Education

BS/BA in Engineering, Chemistry, or Life Sciences

Tools

Balances

Spectrophotometers

Job description

Regeneron is hiring multiple Quality Control (QC) Lab Operation Specialists for a new automated drug substance manufacturing facility in Saratoga Springs, NY. The role supports instrument troubleshooting, method launches, and data integrity in a GMP environment.

Initial location is Rensselaer, NY, with permanent posting in Saratoga Springs. Shifts vary by schedule, with 12-hour nights and day shifts depending on start date, requiring flexibility across schedules.