Quality Systems Specialist

4 weeks ago

Tarrytown, New York, United States Regeneron Pharmaceuticals, Inc Full time

Job Summary: We are seeking a highly skilled Quality Systems Specialist to join our team at Regeneron Pharmaceuticals, Inc. The successful candidate will be responsible for ensuring compliance with all aspects of quality for our manufacturing site, inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.

Key Responsibilities:

  • Ensure compliance with all regulatory requirements and site expectations.
  • Maintain regulatory compliance in accordance with current Good Manufacturing Practices (cGMP).
  • Collaborate with cross-functional teams to resolve issues, complete investigations, and maintain compliance.
  • Review and approve various types of documents, including failure investigations, corrective and preventative actions, standard operating procedures, and GxP documents.
  • Provide administrative support of electronic systems and review procedures, policies, and other instructional documents to ensure compliance with company policy and local and international regulatory requirements.
  • Provision of monitoring and trending metrics associated with site quality systems.
  • Actively participate in continuous improvement ideas, initiation, and implementation.
  • Participate in internal, regulatory, and customer audits.
  • May train personnel on quality system processes and supervise team members.

Requirements:

  • BS/BA in a scientific discipline or related field and 8 years of industry/relevant experience or equivalent combination of education and experience.
  • Excellent written, oral, and interpersonal communication skills, with the ability to effectively interact with a broad spectrum of audiences.
  • Excellent time management, communication, and organizational skills, along with a proven ability to multi-task.
  • Knowledge of quality and cGMP principles and systems, and relevant regulatory guidelines.
  • Project management skills, with the ability to manage many diverse tasks simultaneously.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

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