Senior Quality Control Associate

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 team at Biogen. Your responsibilities will include:

  • Conducting routine quality control testing and managing all associated 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 to address investigations affecting quality.
  • Providing expert technical support during both internal and external audits.
  • Facilitating coaching and promoting continuous improvement initiatives across Quality Systems.
  • Drafting and reviewing controlled documents, protocols, reports, change requests, and validation documents 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 and industry standards.

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 Quality Control.
  • Significant experience in chemistry testing is essential.
  • Experience within pharmaceutical companies focused on human health is necessary.

Additional Insights

At Biogen, we are dedicated 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 effectiveness as a company. Our team is committed to delivering impactful medicines, with every position contributing to our mission of caring deeply, achieving excellence, and changing lives.

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