QC Lab Operations Specialist - GMP & Data Integrity

Regeneron Pharmaceuticals, Inc.; City of Saratoga Springs (NY); On-site; USD 62,000 - 131,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Saratoga Springs, NY is hiring QC Lab Operation Specialists. The role supports QC analysts on instrument issues, method rollouts, and data integrity under cGMP. Transition includes 12‑hour shifts and 1‑weekend duties as needed.

You will troubleshoot chromatography systems and other QC instruments, coordinate maintenance, and contribute to investigations and CAPA closures, ensuring compliant documentation and efficient workflows.

Qualifications

• BS/BA in Engineering, Chemistry, or Life Sciences, may substitute relevant experience for education.
• 2+ years of relevant experience for QC Lab Operation Specialist.
• Experience with laboratory or analytical instrumentation in a GMP environment.
• Working knowledge of FDA cGMP (21 CFR Parts 11 and 211) and ALCOA+ data integrity.
• Experience executing qualification or validation protocols preferred.

Responsibilities

• Serve as the first point of contact for analysts on instrument, software, and workflow issues during testing; triage issues and resolve them or elevate to the appropriate support group.
• Support analysts during first executions of new methods, instruments, or workflows, in coordination with training leads.
• Communicate recurring issues and testing impact to lab leads and the Lab Operations team, including across shift handoffs.
• Troubleshoot hardware, firmware, and software issues on chromatography systems, plate readers, balances, and other QC instrumentation.
• Work with appropriate groups to coordinate service visits, preventive maintenance, and calibration with vendors.
• Confirm instruments are returned to service with required documentation.
• Maintain instrument status, logbooks, and equipment records in accordance with site procedures.
• Work with IT to resolve instrument connectivity issues, including CDS and LIMS interfaces and networked data acquisition.
• Support laboratory investigations (OOS, OOT, invalid assays) and deviations by gathering data, reviewing audit trails and instrument records, and participating in root cause analysis.
• Execute troubleshooting and investigational testing under approved investigation plans.
• Implement assigned CAPAs and support effectiveness checks; track actions to closure.
• Track trends in instrument failures, invalid assays, and recurring errors.
• Execute IQ/OQ/PQ, method verification, engineering run, and dry‑run protocols as assigned, with documentation that meets Good Documentation Practices.
• Document and elevate discrepancies and deviations identified during protocol execution.
• Support post‑implementation monitoring after new instruments, technologies, or lab upgrades are handed over to testing.
• Participate in process mapping of testing, sample management, and reagent preparation workflows; provide floor‑level observations, timing data, and pain points.
• Support implementation of approved workflow changes, including bench layout, sample handling, and procedural updates, under change control.
• Draft or revise SOPs, work instructions, and job aids so they reflect how work is performed on the floor.

Skills

HPLC

GMP environment

ALCOA+ data integrity

Data integrity

Instrument troubleshooting

Education

BS/BA in Engineering, Chemistry, or Life Sciences

Tools

HPLC systems

LIMS interfaces

Job description

Regeneron Pharmaceuticals, Inc. in Saratoga Springs, NY is hiring QC Lab Operation Specialists. The role supports QC analysts on instrument issues, method rollouts, and data integrity under cGMP. Transition includes 12‑hour shifts and 1‑weekend duties as needed.

You will troubleshoot chromatography systems and other QC instruments, coordinate maintenance, and contribute to investigations and CAPA closures, ensuring compliant documentation and efficient workflows.