Regeneron Pharmaceuticals, Inc

QA Investigation Specialist

Regeneron Pharmaceuticals, Inc$66K — $108K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Life Sciences, Engineering, or related field
  • 0-2 years for Associate Specialist level, 2+ years for Specialist level, 5+ years for Senior Specialist level
  • Understanding of biologics manufacturing operations
  • Attention to detail and strong organizational skills
  • Ability to prioritize and manage multiple assignments

Responsibilities

  • Independently investigate non-conformances to prevent reoccurrences
  • Prepare detailed investigation reports for medium/high severity issues
  • Analyze and summarize investigation data for trend reporting
  • Communicate findings and recommendations in group meetings
  • Review batch records and logbooks for cGMP compliance
  • Monitor production processes to gather data for investigations
  • Train new employees on investigative processes and techniques

Benefits

  • Exposure to biologics manufacturing processes
  • Opportunity to lead cross-functional study teams
  • Engagement in compliance and quality assurance tasks
  • Development of investigative skills and techniques
  • Work in a cleanroom environment and gain experience with cGMP standards
Full Job Description
We are currently looking to fill a QA Investigation Specialist position with our Bulk Drug Substance Manufacturing Quality Assurance team. This position performs all compliance related tasks vital to complete investigations and implementation of robust corrective actions for supporting manufacturing operations.

In this role, a typical day might include the following:
  • Independently investigating non conformances and preventing reoccurrences in support of manufacturing operations
  • Preparing investigation reports that include recommendations on investigation findings for medium/high severity non conformances
  • Analyzing and evaluating information captured through investigations, summarizes information and trends in investigation reports
  • Communicating findings and recommendations at group meetings
  • Reviewing completed batch records and logbooks in accordance with cGMP standards in support of investigations
  • Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures
  • Monitoring production processes to acquire vital data in support of investigations and track efficiency of changes
  • Participating in and/or leading cross-functional study teams to get results, support and or author investigations
  • Gathering, trending, and analyzing process related data to drive consistency and timeliness
  • Documenting all training
  • Training new employees on investigative processes and techniques
  • Coordinating and/or leading cross-functional meetings with multiple departments


This role may be for you if you:
  • Excel in a quality driven organization
  • Have an understanding of biologics manufacturing operations
  • Are organized and have an attention to detail
  • Can prioritize multiple assignments and changing priorities
  • Are able to learn and utilize computerized systems for daily performance of tasks


Gowning and Environment:
  • 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


To be considered for this role you must hold a Bachelor's degree in Life Sciences, Engineering, or related field and the following minimum amounts of relevant experience for each level:
  • Associate Specialist - 0-2 years
  • Specialist - 2+ years
  • Senior Specialist - 5+ years


May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

Salary Range (annually)
$66,400.00 - $108,400.00

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

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