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Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Investigation Specialist

Quality Engineering +1Confirmed live in the last 24 hours
Full-timeRensselaer, NY, USA$62.4k - $128.7k /yr

About the Job

Requirements

  • A Bachelor of Science degree in life sciences, engineering, or a related field is required; proven experience may substitute for the education requirement.
  • Related experience requirements vary by level: Associate Investigation Specialist requires 0-2+ years; Investigation Specialist requires 2+ years; Senior Investigation Specialist requires 5+ years. The level is determined based on experience.

Responsibilities

  • Independently investigate non-conformances and prevent their recurrence in support of manufacturing operations.
  • Prepare investigation reports with recommendations on findings for medium- and high-severity non-conformances.
  • Analyze and evaluate information gathered through investigations, and summarize information and trends in investigation reports.
  • Review completed batch records and logbooks in accordance with current Good Manufacturing Practice standards to support investigations.
  • Review, edit, and revise controlled documents, including batch records, logbooks, and standard operating procedures, in accordance with current Good Manufacturing Practice standards and written procedures.
  • Monitor production processes to acquire data supporting investigations and track the efficiency of changes.
  • Participate in and/or lead cross-functional study teams to obtain results and support or author investigations.
  • Gather, trend, and analyze process-related data to drive consistency and timeliness.

About the Company

Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Regeneron Pharmaceuticals develops and commercializes medicines for serious diseases, with a focus on cancer, eye diseases, allergic and inflammatory diseases, and infectious diseases. Its products come from using proprietary research capabilities and technologies to discover and develop therapies, often in collaboration with academic, research, and industry partners. Revenue comes from selling approved medicines and from licensing its technologies and entering co-development and co-commercialization partnerships. The company works with healthcare providers and regulators to ensure treatment delivery and safety. Its goal is to improve patient outcomes by bringing life-transforming medicines to market through rigorous R&D and strategic collaborations, maintaining leadership in biopharmaceutical innovation.

Company size
10,001+
Company stage
IPO
Headquarters
Town of Mount Pleasant, New York
Founded
1988

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