QC Operations & Instrumentation Specialist

Regeneron Pharmaceuticals; Saratoga Springs (UT); Vor Ort; USD 62.000 - 131.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals is hiring multiple QC Operations Specialists for our Saratoga Springs facility. You will provide on-the-floor technical support to QC analysts and lab operations, troubleshoot instruments, and drive deviations and investigations with data review and root cause analysis.

The role requires a BS/BA in Engineering, Chemistry, or Life Sciences and experience with laboratory instrumentation in a GMP environment.

Qualifikationen

• BS/BA in Engineering, Chemistry, or Life Sciences; may substitute relevant experience for education.
• Experience with laboratory or analytical instrumentation in a GMP environment is preferred.
• Working knowledge of FDA cGMP (21 CFR Parts 11 and 211), Good Documentation Practices, and ALCOA+ data integrity principles.

Aufgaben

• 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.
• Coordinate service visits, preventive maintenance, and calibration with vendors and verify instrument return to service with proper documentation.
• Maintain instrument status, logbooks, and equipment records per site procedures.
• Resolve instrument connectivity issues with IT (CDS, LIMS) and data acquisition networks.
• Support laboratory investigations (OOS/OOT) and deviations with data reviews and root cause analysis.
• Execute troubleshooting and investigational testing under approved plans; implement CAPAs and track closure.

Kenntnisse

GMP environment

FDA cGMP

ALCOA+ data integrity

Good Documentation Practices

Instrument troubleshooting

Qualification/Validation

Ausbildung

BS/BA in Engineering, Chemistry, or Life Sciences

Jobbeschreibung

Regeneron Pharmaceuticals is hiring multiple QC Operations Specialists for our Saratoga Springs facility. You will provide on-the-floor technical support to QC analysts and lab operations, troubleshoot instruments, and drive deviations and investigations with data review and root cause analysis.

The role requires a BS/BA in Engineering, Chemistry, or Life Sciences and experience with laboratory instrumentation in a GMP environment.