New · posted Nov 6
Regeneron · Biotechnology
Quality Control Analyst (Reference Standards)
- Rensselaer, NY
- On-site
- Full-time
- Associate & Specialist
The role
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently looking for a Quality Control (QC) Analyst, Reference Standards, to manage the life cycle of reference standards and reference materials in support of the company’s quality program.
What you need
- Requires BS/BA in Life Sciences or related field; will substitute relevant experience for education. Level is settled based on qualifications relevant to the role.
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
- Responsible for life-cycle management of reference standards and reference materials
- Gathers data and documents test results.
- Reviews test results to ensure compliance with standards; reports any quality anomalies.
- Aligns with all pertinent regulatory agency requirements.
- Participates in required training activities.
- Maintains laboratory supplies.
- Writes and revises control test procedures and SOPs.
- Completes test records and reviews data.
- Calibrates or verifies calibration of instruments/devices prior to use.
- Interacts with outside customers or functional peer groups.
- May be responsible for maintaining a specific project.
- May assist in validation of methods.
- May be involved in establishing the transfer of methodology from R&D.
Pay and benefits
$52,499 – $82,098 a year
Employer provided$25.24 – $39.47 an hour · yearly at 2,080 hours (40 a week)
How this comparesSalary Range (hourly)
$25.24 - $39.47
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
Rensselaer, NYOn-siteOpen in Maps (opens in a new tab)
More jobs in Rensselaer, NYWorking conditions
When & where
- Location: Rensselaer, New York, United States
- Work model: 1st | Mon-Fri | 08:00a-04:30p
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 6, 2026
Salary intelligence
How the pay compares
This role's midpoint is 8% below the US median for Quality Control roles at this level.
This roleEmployer provided
Associate & Specialist roles in New York23 roles publishing pay
Associate & Specialist roles in the US84 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $52,499 | — | $82,098 |
| New York (middle half) | $58,000 | $66,000 | $74,500 |
| All US (middle half) | $61,500 | $73,500 | $90,125 |
This role: Regeneron's own published range, converted to a year at 2,080 hours. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 250 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 19 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods8
- Documentation and SOPs4
- GMP and compliance1
- Validation and qualification1
- Regulatory submissions1
- Collaboration and leadership1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Control work in biotechnology, 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 pharmaceuticals
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ISOISO/IEC 17025(official source, opens in a new tab)Competence of testing and calibration laboratories
- 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
- 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
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
- ICHICH Q5 and Q6B(official source, opens in a new tab)Quality of biotechnological products and their specifications
Company hiring pulse
Regeneron on Regulatory Jobs
- 177
- Open roles
- 177
- Distinct roles
- 11
- Locations
By discipline
- Quality75 42%
- Clinical74 42%
- Regulatory29 16%
By level
- Associate & Specialist58 33%
- Manager53 30%
- Director52 29%
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Quality Control Analyst (Reference Standards) at Regeneron
Open until filled. $52K–$82K a year, employer provided.