QC Lab Operations Specialist – Instrument & Data Expert

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

Zusammenfassung

Regeneron Pharmaceuticals is hiring multiple QC Lab Operation Specialists for our Saratoga Springs site. You will provide on-the-floor technical support for QC analysts, troubleshoot instruments and software, and ensure data integrity under ALCOA+ and 21 CFR Parts 11/211 guidelines.

Responsibilities include coordinating service visits, executing qualification/verification, and contributing to process improvements while working with IT and Lab Operations across shift schedules.

Qualifikationen

• BS/BA in Engineering, Chemistry, or Life Sciences; may substitute relevant experience for education.
• 2+ years of relevant QC lab operation experience.
• Experience with laboratory instrumentation (HPLC, GC, balances, spectrophotometers) in a GMP environment preferred.
• Working knowledge of FDA cGMP (21 CFR Parts 11 and 211), Good Documentation Practices, and data integrity principles (ALCOA+) as applied to QC laboratories.
• Experience executing qualification or validation protocols preferred.

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.
• 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

Kenntnisse

GMP experience

ALCOA+ data integrity

Ausbildung

BS/BA in Engineering, Chemistry, or Life Sciences

Associate degree or relevant experience substitution

Tools

HPLC

GC

Balances

Spectrophotometers

CDS/LIMS connectivity

Jobbeschreibung

Regeneron Pharmaceuticals is hiring multiple QC Lab Operation Specialists for our Saratoga Springs site. You will provide on-the-floor technical support for QC analysts, troubleshoot instruments and software, and ensure data integrity under ALCOA+ and 21 CFR Parts 11/211 guidelines.

Responsibilities include coordinating service visits, executing qualification/verification, and contributing to process improvements while working with IT and Lab Operations across shift schedules.