Quality Controls Lab Operations Specialist (Overnights)

Regeneron Pharmaceuticals; Saratoga Springs (UT); On-site; USD 62,000 - 131,000; Full time

Job summary

Regeneron Pharmaceuticals is hiring multiple QC Lab Operation Specialists for our Saratoga Springs site. You will provide on-the-floor technical support for QC analysts, troubleshoot instruments and software, and ensure data integrity under ALCOA+ and 21 CFR Parts 11/211 guidelines.

Responsibilities include coordinating service visits, executing qualification/verification, and contributing to process improvements while working with IT and Lab Operations across shift schedules.

Qualifications

• BS/BA in Engineering, Chemistry, or Life Sciences; may substitute relevant experience for education.
• 2+ years of relevant QC lab operation experience.
• Experience with laboratory instrumentation (HPLC, GC, balances, spectrophotometers) in a GMP environment preferred.
• Working knowledge of FDA cGMP (21 CFR Parts 11 and 211), Good Documentation Practices, and data integrity principles (ALCOA+) as applied to QC laboratories.
• Experience executing qualification or validation protocols preferred.

Responsibilities

• 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 elevate 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

Skills

GMP experience

ALCOA+ data integrity

Education

BS/BA in Engineering, Chemistry, or Life Sciences

Associate degree or relevant experience substitution

Tools

HPLC

GC

Balances

Spectrophotometers

CDS/LIMS connectivity

Job description

Build our future together:

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: Rensselaer, New York, United States
  • Permanent: Saratoga Springs, New York, United States
• Work model:
  • Initial: 1st, Mon- Fri, 8am-4:30pm
  • Permanent: 12-hour shifts, 7pm-7:30am, alternating 3–4 days per week, including 1 weekend day
  • 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 elevate 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 requires:

• BS/BA in Engineering, Chemistry, or Life Sciences, may substitute relevant experience for education
  • Associate QC Lab Operation Specialist: 0-2+ years of relevant experience
  • QC Lab Operation Specialist: 2+ years of relevant experience
  • Sr. QC Lab Operation Specialist: 5+ years of relevant experience
  • Level will be determined based on experience
• Experience with laboratory or analytical instrumentation (e.g., HPLC, GC, balances, spectrophotometers) in a GMP environment is preferred
• Working knowledge of FDA cGMP (21 CFR Parts 11 and 211), Good Documentation Practices, and data integrity principles (ALCOA+) as applied to QC laboratories
• Experience executing qualification or validation protocols preferred

Does this sound like you?

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$62,355.00 - $131,300.00