GMP QC Lab Operations Specialist

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

Job summary

Regeneron is hiring QC Operations Specialists for a state-of-the-art drug substance manufacturing facility in Saratoga Springs, NY. The role provides on-the-floor technical support to QC analysts, troubleshoots instrument and workflow issues, and ensures compliance with cGMP and ALCOA+ principles.

The position involves qualifying and verifying methods, supporting deviations and investigations, and implementing CAPAs.

Qualifications

• BS/BA in Engineering, Chemistry, or Life Sciences; may substitute relevant experience for education.
• Experience with laboratory or analytical instrumentation in GMP environments preferred.
• Familiarity with cGMP (21 CFR Parts 11 and 211) and data integrity (ALCOA+) is required.

Responsibilities

• Serve as the first point of contact for analysts on instrument, software, and workflow issues; triage and resolve or escalate.
• Support analysts during first executions of new methods, instruments, or workflows; coordinate with training leads.
• Communicate recurring issues and testing impact to lab leads and the Lab Operations team; ensure smooth shift handoffs.
• Troubleshoot hardware, firmware, and software issues on chromatography systems, plate readers, balances, and other QC instrumentation.
• Coordinate service visits, preventive maintenance, and calibration with vendors; confirm instruments are back in service with documentation.
• Maintain instrument status, logbooks, and equipment records per site procedures; ensure accuracy and traceability.
• Work with IT to resolve instrument connectivity issues including CDS and LIMS interfaces and network data acquisition.
• Support laboratory investigations (OOS, OOT, invalid assays) and deviations by data review and root cause analysis.
• Execute IQ/OQ/PQ, method verification, engineering run, and dry-run protocols with Good Documentation Practices.

Skills

Troubleshooting

Root cause analysis

GMP compliance

Lab support

Education

BS/BA in Engineering, Chemistry, or Life Sciences

Tools

HPLC

GC

Balances

Spectrophotometers

Job description

Regeneron is hiring QC Operations Specialists for a state-of-the-art drug substance manufacturing facility in Saratoga Springs, NY. The role provides on-the-floor technical support to QC analysts, troubleshoots instrument and workflow issues, and ensures compliance with cGMP and ALCOA+ principles.

The position involves qualifying and verifying methods, supporting deviations and investigations, and implementing CAPAs.