Regeneron Pharmaceuticals, Inc

QA Specialist, Drug Product

Regeneron Pharmaceuticals, Inc • $62K — $110K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • B.S. in life sciences or related field; equivalent experience considered
  • 2+ years of experience for Associate QA Specialist
  • 4+ years of experience for QA Specialist
  • Experience in quality assurance and drug product operations
  • Ability to perform physical tasks required in a clean room environment

Responsibilities

  • Lead efforts to establish new programs for drug product operations
  • Assess existing procedures and documents for adequacy
  • Develop, write, and review SOPs and specifications
  • Maintain project timelines to support QA initiatives
  • Perform quality review of documents on the manufacturing floor
  • Mentor staff during on-the-floor manufacturing
  • Support audits and investigations for compliance

Benefits

  • Student loan paydown program & tuition reimbursement
  • Family care benefits
  • Relocation assistance
  • Programs for inclusion, culture, and well-being (physical & mental health)
Full Job Description

Regeneron is currently seeking a Quality Assurance (QA) Specialist to join our QA Drug Product team. This position will support QA initiatives for a broad range of topics relative to the start-up and operations of a drug product facility. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

  • 1st shift, Monday-Friday, 8am-4:30pm
  • Location: Rensselaer, New York, United States

What you’ll do:

  • Work on and potentially lead efforts to establish new programs including start-up of formulation, filling, inspection, assembly, and pack and label team
  • Perform assessments of existing procedures/documents to gauge appropriateness for the inclusion of drug product operations; where current documents are not adequate, identify path forward for establishment of procedures
  • Develop, write, review, and approve SOPs, specifications, and other documents. This includes documents for operation and facility SOPs, quality training, batch documentation, etc.
  • Maintain project timelines to support the evolving business
  • Perform on-the-floor quality review of documents, such as: equipment logs, training records, testing results, batch records and supporting documents
  • Review and approval of documents (electronic and paper-based)
  • Provide mentorship during on-the-floor manufacturing
  • Support audits, inspections and investigations
  • Perform quarantine, segregation of material and line clearances
  • Contribute to the continuous improvement initiatives
  • Adjust schedule based on facility start up, filling, and manufacturing needs
  • Collaborate with cross-functional internal teams

The environment and physical rhythms of this role:

  • Gowning: full cleanroom attire (examples may include: including 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
  • Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment
  • Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs

Let’s find out if we’re a fit:

  • Requires B.S in life sciences or related field; may substitute proven experience for education requirement
    • Assoc QA Specialist : 2+ years of experience
    • QA Specialist : 4 + years of experience
  • Level will be determined based on experience

Thrive today. Grow tomorrow.

  • Student loan paydown program & tuition reimbursement
  • Family Care Benefits
  • Relocation assistance
  • Inclusion, culture and well-being programs (including physical & mental health)

Salary Range (annually)

$62,355.00 - $110,000.00

About Regeneron Pharmaceuticals, Inc

Regeneron Pharmaceuticals is a biopharmaceutical company that discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions. The Company has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. The company’s product portfolio includes EYLEA, an aflibercept injection; ARCALYST, a rilonacept Injection for subcutaneous use; ZALTRAP for metastatic colorectal cancer; trap fusion proteins; and fully human monoclonal antibodies. On March 26, 2012, it was announced that Sanofi and Regeneron are in development with a new cholesterol drug which will help reduce cholesterol up to 72%. Regeneron Pharmaceuticals was founded in 1988 and is currently headquartered in New York, USA.

Regeneron Pharmaceuticals, Inc Careers

Join the innovative team at Regeneron Pharmaceuticals, Inc, a leading biotechnology company renowned for its commitment to science-driven solutions. This is an unparalleled opportunity to advance your career with a company at the forefront of medical breakthroughs and clinical research.

Work You’ll Do

At Regeneron Pharmaceuticals, Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that directly contributes to the health and well-being of populations globally. Our diverse team of professionals is dedicated to pioneering developments in biotechnology through continuous innovation and rigorous research.

Explore Job Opportunities and Growth

Regeneron offers a variety of job opportunities that encourage professional growth and personal achievement. Whether you're seeking an entry-level position or a more senior role, you will find a path that aligns with your career ambitions and skills. Our supportive culture emphasizes leadership development and diversity training, ensuring every team member can thrive.

Internship Programs

Kickstart your career with a Regeneron internship. Our programs provide invaluable industry experience, mentoring from seasoned professionals, and opportunities to develop skills that are crucial in the biotech field. Interns at Regeneron gain hands-on experience, contributing to projects that matter.

Benefits and Culture

Choosing to work at Regeneron Pharmaceuticals, Inc means choosing a career that comes with competitive benefits designed to support you both professionally and personally. We offer comprehensive health benefits, retirement plans, and wellness programs. Our inclusive culture fosters an environment where every employee can flourish, driven by collaboration and mutual respect.

Innovation and Leadership

Lead the way in biotechnological innovation with Regeneron. Our leadership is constantly looking towards the future, investing in cutting-edge technology and research that pave the way for medical advancements. At Regeneron, leadership and innovation go hand in hand, creating a dynamic where breakthroughs are common.

Networking and Professional Development

Enhance your professional network and skill set through Regeneron’s extensive networking opportunities and ongoing professional development programs. We believe in nurturing our talent with advanced training sessions and regular workshops that cover the latest trends and technologies in the biotech industry.

Join Our Team

Discover the impact you can make in a career at Regeneron Pharmaceuticals, Inc. Search for open positions that match your skills and interests. We are continuously hiring and looking for passionate, curious, and innovative team players.

Stay Connected

Keep up to date with the latest at Regeneron by following our careers blog. Gain insights from the experts and learn more about the exciting world of biotech at Regeneron Pharmaceuticals, Inc.

Prepare for Your Interview

Ready to join us? Prepare your resume and refine your interview skills to become part of a company that’s dedicated to changing lives. Personalize your job search and get tailored job alerts directly to your inbox, so you never miss an opportunity to be part of our team. At Regeneron Pharmaceuticals, Inc, your career is poised for tremendous growth and innovation. Explore the opportunities today and be part of a team that’s shaping the future of biotechnology.
Learn more about Regeneron Pharmaceuticals, Inc
Size
10,368 employees
Market Cap
$78.1 billion
Industry
Net Income
$3.5 billion
Founded
1988
5 Year Trend
+27%
Revenue
$8.4 billion
NASDAQ

Similar Jobs

More Jobs at Regeneron Pharmaceuticals, Inc

More Pharmaceuticals & Biotech Jobs

Find similar QA Specialist, Drug Product jobs: