Lead Associate, Quality Control

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 supporting the operational and tactical functions of the Quality Control department within our organization. Your responsibilities will encompass a variety of essential tasks, including:

  • 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 relevant regulatory requirements and serving as a subject matter expert across multiple areas, collaborating with key stakeholders in Quality Assurance, Global Quality Control, Supply Chain, and Regulatory Affairs.
  • Providing expert technical assistance during both internal and external audits.
  • Facilitating coaching and promoting continuous improvement initiatives across all Quality Systems.
  • Authoring and reviewing essential documentation, including controlled documents, investigational protocols, and validation reports, 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 with both company and industry standards within the laboratory and Quality systems.
Qualifications
  • A degree in Pharmacy, Chemistry, or Biological Sciences.
  • Proficiency in English (intermediate to advanced level, both spoken and written).
  • A minimum of 5 years of experience in Quality Control.
  • Significant experience in chemistry testing is essential.
  • Experience within the pharmaceutical sector, particularly in human health, is required.
Why Join Us?

At Biogen, we pride ourselves on our commitment to excellence and innovation. As a mid-sized biotechnology firm, we offer the stability and resources of an established organization while fostering an environment that values individual contributions. Our team consists of talented professionals dedicated to learning, growth, and skill enhancement. Together, we strive to deliver transformative medicines, with each role being integral to our mission.

We are dedicated to nurturing a culture of inclusion and belonging that mirrors the diverse communities we serve. We recognize that varied backgrounds, cultures, and perspectives enhance our strength and creativity as a company. Our focus is on building teams where every employee feels valued and inspired.

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