Quality Control Operations Specialist

Regeneron Pharmaceuticals • Saratoga Springs, UT

3d • $62,355 - $131,300 • Onsite

About The Position

Regeneron is hiring multiple Quality Control (QC) 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 laboratory operations, using a working understanding of laboratory workflows, instruments, and sample and data flow. The specialist troubleshoots instrument, method, and system issues in real time; supports deviations and investigations through data and audit trail review and root cause analysis; executes qualification and verification protocols; and contributes to workflow improvements. The role applies cGMP requirements (21 CFR Parts 11 and 211) and ALCOA+ principles and escalates compliance concerns through quality channels.

The position starts at the Rensselaer, New York location on a first-shift Monday–Friday schedule, 8:00 a.m.–4:30 p.m. The permanent location is Saratoga Springs, New York, with 12-hour shifts from 7:00 a.m.–7:30 p.m., alternating three to four days per week and 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, facemask, 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 position level—Associate QC Lab Operations Specialist, QC Lab Operations Specialist, or Senior QC Lab Operations Specialist—will be determined based on experience.

Regeneron describes a competitive and comprehensive total rewards package that 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, depending on country and role.

Requirements

• BS/BA in Engineering, Chemistry, or Life Sciences; relevant experience may be substituted for education.
• Relevant experience by level: Associate QC Lab Operations Specialist, 0–2+ years; QC Lab Operations Specialist, 2+ years; Senior QC Lab Operations Specialist, 5+ years.
• 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 12-hour schedule, 7:00 a.m.–7:30 p.m., 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, and workflow issues during testing; triage, resolve, or escalate issues 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 on chromatography systems, plate readers, balances, and other QC instrumentation.
• Coordinate service visits, preventive maintenance, and calibration with vendors and appropriate groups, and 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, including OOS, OOT, and 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, support effectiveness checks, and 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 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 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 to reflect how work is performed on the floor.

Benefits

• Annual bonuses or other incentive plans may be offered, depending on country and role.
• Equity awards may be offered, depending on country and role.
• Pension or retirement benefits may be offered, depending on country and role.
• 401(k) company match.
• Health and wellness programs.
• Fitness centers.
• Insurance benefits, including medical, dental, vision, life, and disability coverage.
• Paid time off.
• Family support benefits.

What This Job Offers

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