Quality Controls Lab Operations Specialist (Overnights)

Regeneron Pharmaceuticals • Saratoga Springs, UT

6d • $62,355 - $131,300 • Onsite

About The Position

Regeneron is hiring multiple Quality Control (QC) Lab Operations Specialists for its new highly automated drug substance manufacturing facility in Saratoga Springs. The role provides on-the-floor technical support to QC analysts and the lab operations team, with a working understanding of laboratory workflows, instruments, and sample and data flow. It 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. The specialist contributes to workflow improvements and applies cGMP (21 CFR Parts 11 and 211) and ALCOA+ principles, escalating compliance concerns through quality channels.

The initial work location is Rensselaer, New York, with a permanent location in Saratoga Springs, New York. Initially, the schedule is Monday through Friday, 8:00 a.m. to 4:30 p.m. The permanent schedule consists of 12-hour overnight shifts, 7:00 p.m. to 7:30 a.m., on alternating three- to four-day weeks, including one weekend day. 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.

The position requires full cleanroom attire, which may include laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves, and sanitizing agents such as IPA during gowning. Employees must be able to remove jewelry, makeup, and nail adornments when wearing cleanroom attire. The role may be filled at Associate QC Lab Operation Specialist, QC Lab Operation Specialist, or Senior QC Lab Operation Specialist level; level will be determined based on experience.

Requirements

• A BS/BA in Engineering, Chemistry, or Life Sciences; relevant experience may be substituted for education.
• Relevant experience by level: 0–2+ years for Associate QC Lab Operation Specialist, 2+ years for QC Lab Operation Specialist, or 5+ years for Senior QC Lab Operation Specialist. Level is determined based on experience.
• Working knowledge of FDA cGMP (21 CFR Parts 11 and 211), Good Documentation Practices, and data integrity principles (ALCOA+) as applied to QC laboratories.
• Ability to work both the initial Monday–Friday, 8:00 a.m.–4:30 p.m. schedule and the permanent 7:00 p.m.–7:30 a.m. schedule on alternating three- to four-day weeks, including one weekend day.
• Ability to wear full cleanroom attire and remove jewelry, makeup, and nail adornments while wearing it.

Nice To Haves

• Experience with laboratory or analytical instrumentation such as HPLC, GC, balances, or spectrophotometers in a GMP environment.
• Experience executing qualification or validation protocols.

Responsibilities

• Serve as the first point of contact for analysts experiencing instrument, software, or workflow issues during testing; triage issues and resolve them or escalate them 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 their impact on testing to lab leads and the Lab Operations team, including during shift handoffs.
• Troubleshoot hardware, firmware, and software issues on chromatography systems, plate readers, balances, and other QC instrumentation.
• Coordinate vendor service visits, preventive maintenance, and calibration with appropriate groups; 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 OOS, OOT, and invalid-assay investigations 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, support effectiveness checks, and track actions through 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, documenting work according to Good Documentation Practices.
• Document and escalate discrepancies and deviations identified during protocol execution.
• Support post-implementation monitoring after new instruments, technologies, or laboratory upgrades are handed over to testing.
• Participate in process mapping of testing, sample management, and reagent preparation workflows, providing floor-level observations, timing data, and identified pain points.
• Support approved workflow changes, including bench layout, sample handling, and procedural updates, under change control.
• Draft or revise SOPs, work instructions, and job aids to reflect how work is performed on the floor.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level