Biogen Quality Assurance Specialist

3 days ago


Denver, North Carolina, United States Biogen Full time
Quality Assurance Specialist

We are seeking a highly skilled Quality Assurance Specialist to join our team at Biogen. This role will be responsible for ensuring product disposition documentation and other supporting documents are compliant with regulatory requirements.

About the Role:

  • Coordinate batch disposition cross-functionally and ensure compliance with cGMP production activities and/or release of product for further processing and/or distribution.
  • Provide technical consultation for quality-related issues and ensure compliance with regulatory requirements and site procedures.
  • Assess criticality of exceptions/investigations for product impact, perform thorough reviews of investigations, and identify potential areas within the process that may have contributed to the exception.
  • Review documents for compliance and identify gaps in existing quality systems, propose solutions, and drive cross-functional improvement initiatives.
  • Mentor and train less experienced associates across Quality Assurance functions, serving as a technical subject matter expert (SME) in support of department functions.

Requirements:

  • Bachelor's Degree in Life Science or other technical discipline.
  • Minimum 7 years directly related to position responsibilities; or Master of Business Administration or Master of Science Degree (MBA/MS) with 5+ years related experience.
  • Expertise in batch disposition of drug substance, including interpretation of specifications for various markets, in a cGMP environment.
  • Excellent written, verbal & interpersonal communication skills required to condense complex subjects into key bullet points, articulate recommendations, decisions to Quality Management, develop strong networks cross-functionally to drive collaboration, processes & decisions.
  • Knowledge of relevant FDA/EMA regulations and compliance.
  • Strong organizational skills; ability to multi-task and coordinate multiple activities in parallel.

Estimated Salary: $120,000 - $150,000 per year.

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills.

We are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.



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