New · posted Nov 4
Regeneron · Biotechnology
Quality Control Operations Specialist (Overnights)
- Saratoga Springs, NY
- On-site
- Full-time
- Associate & Specialist
The role
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.
What you need
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
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/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
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.
What you'll do
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 escalate 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 escalate 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
Pay and benefits
$62,355 – $131,300 a year
Employer provided$62,355.00 - $131,300.00
Annual bonuses or incentive plans
Equity awards
401(k) company match
Health and wellness programs
Medical, dental, vision, life and disability insurance
Paid time off
Where you'll work
Saratoga Springs, NYOn-siteOpen in Maps (opens in a new tab)
More jobs in Saratoga Springs, NYWorking conditions
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
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, 7am-7:30pm, 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.
Equal opportunity, accessibility and legal noticesRegeneron's statements, word for word
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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.
Job intelligence
The context around this role
Live data · November 4, 2026
Salary intelligence
How the pay compares
This role's midpoint is 33% above the US median for Quality Control roles at this level.
This roleEmployer provided
Associate & Specialist roles in New York22 roles publishing pay
Associate & Specialist roles in the US79 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $62,355 | — | $131,300 |
| New York (middle half) | $58,000 | $66,000 | $75,750 |
| All US (middle half) | $59,250 | $73,000 | $88,250 |
This role: Regeneron's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, November 4, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 242 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Regeneron's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods17
- Documentation and SOPs7
- Data and digital systems5
- GMP and compliance4
- Investigations and CAPA4
- Clinical trial conduct4
- Collaboration and leadership4
- Validation and qualification3
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Control work in biotechnology, led by the three this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical ProductionNamed in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- ISOISO/IEC 17025(official source, opens in a new tab)Competence of testing and calibration laboratories
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- FDAFDA analytical procedures guidance(official source, opens in a new tab)Analytical Procedures and Methods Validation for Drugs and Biologics
- ICHICH Q1 stability testing(official source, opens in a new tab)Stability testing of drug substances and drug products
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- ICHICH Q3 impurities(official source, opens in a new tab)Impurities in drug substances and products, residual solvents and elemental impurities
Company hiring pulse
Regeneron on Regulatory Jobs
- 169
- Open roles
- 144
- Distinct roles
- 11
- Locations
By discipline
- Clinical71 42%
- Quality70 41%
- Regulatory28 17%
By level
- Associate & Specialist56 33%
- Director50 30%
- Manager48 28%
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Quality Control Operations Specialist (Overnights) at Regeneron
Open until filled. $62K–$131K a year, employer provided.