Quality Controls Lab Operations Specialist (Overnights)

Regeneron Pharmaceuticals • Saratoga Springs, NY

5d • Onsite

About The Position

Regeneron is hiring multiple Quality Control (QC) Lab Operations Specialists for its highly automated drug substance manufacturing facility. The role provides on-the-floor technical support to QC analysts and lab operations, requiring an understanding of assigned laboratories’ workflows, instruments, and sample and data flow. The specialist troubleshoots instrument, method, software, and system issues; supports laboratory investigations and deviations; executes qualification and verification protocols; and contributes to workflow improvements. The position applies cGMP requirements, including 21 CFR Parts 11 and 211, and ALCOA+ data integrity principles, escalating compliance concerns through quality channels.

The position initially works in Rensselaer, New York, on a Monday–Friday, 8:00 a.m.–4:30 p.m. schedule. The permanent location is Saratoga Springs, New York, with 12-hour overnight shifts from 7:00 p.m. to 7:30 a.m., alternating three to four days per week, 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 role requires full cleanroom attire, which may include laundered undergarments, a gown, face mask, hairnet, safety glasses, safety shoes and booties, latex gloves, and sanitizing agents such as IPA during gowning. Jewelry, makeup, and nail adornments must be removed when wearing cleanroom attire. The role is offered at associate, specialist, or senior specialist level, determined by experience.

Requirements

• A BS/BA in Engineering, Chemistry, or Life Sciences; relevant experience may be substituted for education.
• Relevant experience by level: Associate QC Lab Operation Specialist, 0–2+ years; QC Lab Operation Specialist, 2+ years; Senior QC Lab Operation Specialist, 5+ years. 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 day schedule and the permanent overnight schedule of 12-hour shifts, alternating three to four days per week and 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, 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 testing impacts to lab leads and the Lab Operations team, including across shift handoffs.
• Troubleshoot hardware, firmware, and software issues involving chromatography systems, plate readers, balances, and other QC instrumentation.
• Coordinate instrument service visits, preventive maintenance, and calibration with vendors and relevant 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, invalid-assay, and deviation investigations by gathering data, reviewing audit trails and instrument records, and participating in root cause analysis.
• Perform troubleshooting and investigational testing under approved investigation plans.
• Implement assigned CAPAs, support effectiveness checks, and track actions to closure.
• Track trends in instrument failures, invalid assays, and recurring errors.
• Execute assigned IQ/OQ/PQ, method verification, engineering run, and dry-run protocols with documentation that meets 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, insurance benefits, paid time off, and family support benefits.

What This Job Offers

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