Lead Associate in Quality Assurance

hace 2 meses

Buenos Aires, Argentina Biogen A tiempo completo
Position Overview

As a Senior Quality Control Associate, you will play a crucial role in the operational and tactical functions of the Quality Control department at Biogen. Your responsibilities will include:

  • Conducting routine quality control assessments and ensuring all testing activities comply with current Good Manufacturing Practices (cGMP).
  • Maintaining compliance with regulatory standards and serving as a knowledgeable resource across various disciplines, collaborating with Quality Assurance, Global Quality Control, Supply Chain, and Regulatory Affairs.
  • Providing expert technical assistance during both internal and external audits.
  • Facilitating coaching and driving continuous improvement initiatives across Quality Systems.
  • Preparing and reviewing essential documentation, including investigational protocols, reports, change control requests, and validation documents.
  • Leading method transfer, development, qualification, and analytical enhancement projects in partnership with the Analytical Technology/Development team.
  • Assisting management in ensuring that laboratory operations and Quality systems adhere to Biogen's standards and industry regulations.
Qualifications
  • A degree in Pharmacy, Chemistry, or Biological Sciences.
  • Proficiency in English, both spoken and written, at an intermediate to advanced level.
  • A minimum of 5 years of experience in a Quality Control role.
  • Extensive experience in chemistry testing is essential.
  • Experience within the pharmaceutical sector, particularly in human health, is required.
Why Join Biogen?

At Biogen, we are dedicated to fostering a culture of excellence and innovation. As a mid-sized biotechnology firm, we combine the stability of an established organization with an environment that encourages individual contributions and growth. Our team is composed of talented professionals who are passionate about making a difference in the lives of patients through life-changing therapies.

We are committed to promoting diversity and inclusion within our workforce, reflecting the communities we serve. We believe that a variety of backgrounds and perspectives enhances our creativity and effectiveness as a company. Join us in our mission to deliver impactful solutions in healthcare.

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