Full-Time

QA Specialist

Batch Record Review

Posted on 4/12/2025

Regeneron Pharmaceuticals

Regeneron Pharmaceuticals

10,001+ employees

Develops biopharmaceuticals for serious diseases

Compensation Overview

$59.7k - $126.8k/yr

Mid, Senior

Albany, NY, USA

Category
QA & Testing
Quality Assurance
Requirements
  • Bachelor’s degree
  • 2+ years of relevant experience for Associate QA Specialist
  • 4+ years of relevant experience for QA Specialist
  • 6+ years of relevant experience for Sr QA Specialist
  • Understanding of biologics manufacturing operations
  • Organizational skills
  • Attention to detail
  • Ability to learn and utilize computerized systems
Responsibilities
  • Representing Quality Assurance in support of sophisticated Deviations, Change Controls, CAPAs, etc.
  • Participate as a QA representative on Technology Transfer Startup Teams
  • Providing consultation or advice in alignment with QA policies
  • Reviewing completed records and batch sheets
  • Working with other departments and communicate internally and externally effectively
  • Performing activities associated with disposition of product
  • Reviewing, editing, or approving Regeneron controlled documents
  • Performing status labeling of product
  • Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement
Desired Qualifications
  • Excel in a quality driven organization
  • Can prioritize multiple assignments and changing priorities
Regeneron Pharmaceuticals

Regeneron Pharmaceuticals

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Regeneron Pharmaceuticals develops medicines aimed at treating serious diseases such as cancer, eye diseases, and allergic conditions. The company uses its own technologies and extensive research to create new therapies, often collaborating with academic institutions and other pharmaceutical companies to enhance its development efforts. Unlike many competitors, Regeneron focuses on both research and commercialization, generating revenue through the sale of its approved medicines and strategic partnerships. The goal of Regeneron is to improve patient outcomes by providing effective treatments and ensuring that its products meet high safety and efficacy standards.

Company Size

10,001+

Company Stage

IPO

Headquarters

Town of Greenburgh, New York

Founded

1988

Simplify Jobs

Simplify's Take

What believers are saying

  • Dupixent's approval for COPD in Japan expands Regeneron's market presence in Asia.
  • Regeneron's proposal for longer Eylea HD dosing could improve patient compliance.
  • Positive data for Dupixent in bullous pemphigoid expands its dermatology portfolio.

What critics are saying

  • Dupixent's label expansion for CSU faces challenges due to previous FDA rejection.
  • Dr. Matthew Sleeman's departure may disrupt ongoing research projects.
  • Investment in Adverum Biotechnologies could be risky if gene therapy programs fail.

What makes Regeneron Pharmaceuticals unique

  • Regeneron specializes in life-transforming medicines for serious diseases.
  • The company leverages proprietary technologies for innovative drug development.
  • Regeneron collaborates with academic and research institutions to enhance R&D efforts.

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Benefits

Health Insurance

Wellness Program

Paid Vacation

Equity Awards

Annual Bonuses

Flexible Work Hours

Company News

BioSpace
Apr 14th, 2025
Fda Action Alert: Regeneron, Sanofi And Abeona

The FDA has three big decisions slated for the back half of April, two of which are for Regeneron’s blockbuster franchises.Read below for more.Regeneron, Sanofi Eye Another Expansion for DupixentFollowing an initial rejection in October 2023, Regeneron and Sanofi are again trying to expand their anti-inflammatory antibody Dupixent into chronic spontaneous urticaria (CSU). The FDA’s decision is due on April 18.To support their bid for label expansion, the pharma partners submitted data from the Phase III LIBERTY-CUPID clinical program. Data from Study A, released in July 2021, showed that Dupixent could nearly double itch reduction and urticaria activity scores versus antihistamines. Study B, meanwhile, found a numeric improvement in itching and hives versus antihistamines in patients refractory to omalizumab, as per a February 2022 readout, though the study did not reach statistical significance. It was terminated due to futility.These two studies formed the backbone of Dupixent’s initial failed attempt at an approval for CSU, which the FDA rebuffed due to the lack of efficacy data. In their resubmission, Regeneron and Sanofi filed additional data from a third trial, dubbed Study C, which also showed a nearly 50% drop in itch and urticaria activity.If approved, Dupixent would be the first targeted option for CSU in a decade, according to a November 2024 news release.Regeneron Proposes Longer Dosing Interval for Eylea HDIn a bid to maintain the market dominance of its blockbuster biologic Eylea, Regeneron is working to improve the product profile of the high-dose (HD) formulation of the drug

MarketBeat
Apr 4th, 2025
Insider Buying: Adverum Biotechnologies, Inc. (NASDAQ:ADVM) Major Shareholder Purchases 15,209 Shares of Stock

Regeneron Pharmaceuticals Inc. purchased a new stake in Adverum Biotechnologies in the 4th quarter valued at about $845,000.

PharmiWeb
Mar 28th, 2025
Dupixent Approved As The First-Ever Biologic Medicine In Japan For Patients With Copd

Following recent approvals in the EU, China, and the US, this approval was based on pivotal phase 3 results in adults with elevated eosinophilsApproval marks the first new treatment approach for COPD in more than a decade in Japan and the sixth approved indication for chronic diseases with underlying type 2 inflammationParis and Tarrytown, NY, March 28, 2025. The Ministry of Health, Labour and Welfare in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy.The approval in Japan was based on data from the landmark BOREAS phase 3 study. The study evaluated Dupixent added to background maximal standard-of-care inhaled therapy (with nearly all patients on triple therapy or double therapy if inhaled corticosteroids were contraindicated) in adults with uncontrolled COPD and elevated blood eosinophils. In the study, Dupixent significantly reduced exacerbations and improved lung function compared to placebo. Safety results in the study were generally consistent with the known safety profile of Dupixent in its approved indications. The most commonly reported adverse event with Dupixent was injection site reaction

Investing.com
Mar 19th, 2025
Aadi Bioscience Inc (AADI) Q4 2024 Earnings Call Highlights: Strategic Transition and Financial...

Q & A Highlights Q: Considering that Regeneron is developing a Mucin 16 targeted bispecific antibody for ovarian cancer, how do you anticipate the clinical activity and safety profile of your ADC might compare to the bispecific approach within this indication?

PR Newswire
Mar 11th, 2025
Regeneron Science Talent Search 2025 Awards More Than $1.8 Million To High School Seniors For Innovative Research On Classifying Celestial Objects, Treating A Rare Muscle Disease And Solving A Long-Standing Math Problem

$250,000 top award goes to Matteo Paz in America's longest running and most distinguished science and math competitionTARRYTOWN, N.Y. and WASHINGTON, March 11, 2025 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. and Society for Science (the Society) announced that Matteo Paz, 18, of Pasadena, California, won the top award of $250,000 in the 2025 Regeneron Science Talent Search, the U.S.'s oldest and most prestigious science and math competition for high school seniors.Congratulations to the top three Regeneron Science Talent Search award winners, Ava Grace Cummings, Matteo Paz and Owen Jianwen Zhang (left to right) Photo Credit: Chris Ayers Photography/Licensed by Society for ScienceNow in its 84th year, the competition celebrates and rewards young innovators who are applying their Science, Technology, Engineering and Math (STEM) talent and leadership skills to push the boundaries of discovery and address today's pressing challenges.Forty finalists, including Matteo, were honored this evening during an award ceremony at the National Building Museum in Washington, D.C, where they were awarded more than $1.8 million in prizes for their groundbreaking research, exceptional problem-solving skills and potential to shape the future of STEM.Matteo Paz , 18, of Pasadena, California , won first place and $250,000 for designing machine-learning algorithms to efficiently comb through 200 billion entries of raw NEOWISE infrared full-sky data. By analyzing tiny changes in infrared radiation, the AI sorted the objects into 10 classes. He found 1.5 million new potential objects.won first place and for designing machine-learning algorithms to efficiently comb through 200 billion entries of raw NEOWISE infrared full-sky data. By analyzing tiny changes in infrared radiation, the AI sorted the objects into 10 classes

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