Quality Controls Lab Operations Specialist; Overnights

Team:
Industrial Operations & Product Supply

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are hiring multiple Quality Control (QC) Lab Operation Specialists to join our team at our new highly automated drug substance manufacturing facility in Saratoga Springs.

The QC Lab Operations Specialist provides on-the-floor technical support to QC analysts and the lab operations team, with a working understanding of assigned labs’ workflows, instruments, and sample and data flow. The role troubleshoots instrument, method, and system issues in real time, supports deviations and investigations through data and audit trail review and root cause analysis, and executes qualification and verification protocols.

They will contribute to workflow improvements and apply cGMP (21 CFR Parts 11 and 211) and ALCOA+ principles, escalating compliance concerns through quality channels.

When & where:

• Location:
• Initial: 1st, Mon
  - Fri, 8am-4:30pm
• Transition: candidates must be able to work both schedules. The permanent shift start date will be communicated with reasonable advance notice and is subject to business needs.

Discover your role:

• 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 escalated 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

The environment and physical rhythms of the role:

• Gowning:
  Full cleanroom attire (examples may include laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

This role…