Quality Control Operations Specialist

Regeneron Pharmaceuticals • Saratoga Springs, NY

1d • Onsite

About The Position

Regeneron is hiring multiple Quality Control (QC) Operations Specialists for its highly automated drug substance manufacturing facility. The role provides on-the-floor technical support to QC analysts and laboratory operations teams, with a working understanding of laboratory workflows, instruments, and sample and data flow. Specialists troubleshoot instrument, method, and system issues in real time; support deviations and investigations through data and audit-trail review and root-cause analysis; and execute qualification and verification protocols. They also contribute to workflow improvements and apply 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. The initial schedule is Monday through Friday, 8:00 a.m. to 4:30 p.m. The permanent schedule consists of 12-hour shifts from 7:00 a.m. to 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. Employees must be able to remove jewelry, makeup, and nail adornments when wearing cleanroom attire. The position may be filled at Associate, Specialist, or Senior Specialist level based on experience.

Requirements

• A BS/BA in Engineering, Chemistry, or Life Sciences; relevant experience may substitute 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. Level will be 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 schedule and the permanent 12-hour shift schedule, including one weekend day per week as scheduled.
• 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, and 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 and resolve issues 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 laboratory 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 instrument service visits, preventive maintenance, and vendor calibration; 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 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; provide floor-level observations, timing data, and pain points.
• Support approved workflow changes under change control, including bench layout, sample handling, and procedural updates.
• 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