Quality Control Senior Specialist

hace 2 semanas


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 testing and managing all related activities in compliance with current Good Manufacturing Practices (cGMP), including microbiological and physico-chemical assessments of products intended for market release.
  • Ensuring compliance with all regulatory requirements and serving as a subject matter expert across various disciplines, collaborating with key stakeholders in Quality Assurance, Global Quality Control, Supply Chain, and Regulatory Affairs.
  • Providing expert technical support during both internal and external audits.
  • Facilitating coaching and driving continuous improvement initiatives across Quality Systems.
  • Drafting and reviewing essential documents such as controlled documents, investigational protocols, reports, change control requests, and validation documentation in accordance with established procedures.
  • Leading projects related to method transfer, development, qualification, and validation of analytical methods in partnership with the Analytical Technology/Development team.
  • Assisting management in maintaining compliance of laboratory and Quality systems with Biogen’s standards and industry regulations.

Required Qualifications

  • Degree in Pharmacy, Chemistry, or Biological Sciences.
  • Proficiency in English (intermediate to advanced level, both spoken and written).
  • At least 5 years of experience in a Quality Control role.
  • Significant experience in chemistry testing is essential.
  • Background in pharmaceutical companies focusing on human health is required.

Additional Insights

Why Choose Biogen?

Biogen is a dynamic mid-sized biotechnology firm that combines the stability of an established organization with a culture that values individual contributions. Our team is composed of talented professionals dedicated to learning, growth, and skill enhancement. Together, we strive to deliver transformative medicines, with every position being integral to our mission. We are committed to fostering a culture of inclusion and belonging that mirrors the diverse communities we serve. We believe that a variety of backgrounds, cultures, and perspectives enhance our innovation and strength as a company.



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