Quality Control Senior Associate

hace 2 semanas

Buenos Aires, Argentina Biogen A tiempo completo

About This Position

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 encompass:

  • Conducting routine quality control testing and managing all associated activities in compliance with cGMP standards, including microbiological and physico-chemical assessments of final products.
  • 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 promoting continuous improvement across all Quality Systems.
  • Drafting and reviewing controlled documents, including investigational protocols, reports, change control requests, and validation documents in accordance with established procedures.
  • Leading method transfer, development, qualification, and analytical improvement initiatives in partnership with the Analytical Technology/Development team.
  • Assisting management in maintaining compliance with Biogen's standards and industry regulations within the laboratory and Quality systems.

Qualifications

  • 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.
  • Extensive experience in chemistry testing is essential.
  • Experience in the pharmaceutical sector (human health) is required.

Additional Information

Why Choose Biogen?

At Biogen, we are dedicated to excellence and innovation. As a mid-sized biotechnology firm, we offer the stability and resources of an established organization while nurturing an environment that values individual contributions. Our team consists of talented professionals who are passionate about learning, growth, and skill enhancement. Together, we strive to deliver transformative medicines, with each role being integral to our mission. We prioritize a culture of inclusion and belonging, reflecting the diverse communities we serve. We believe that varied backgrounds and perspectives strengthen our company and drive innovation.

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