Senior Quality Assurance Associate

2 months ago

Durham, North Carolina, United States Biogen Full time
About This Role

We are seeking a highly skilled Sr. Associate II, Quality Assurance to join our team at Biogen Research Triangle Park (RTP) facility. As a key member of our Quality Assurance team, you will be responsible for overseeing strategic, tactical, and operational aspects of Quality Assurance, ensuring compliance with regulatory requirements and site procedures.

Key Responsibilities
  • Ensure Product Disposition documentation and other supporting documents are compliant and determine acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution.
  • Serve as a highly skilled technical consultant for quality-related issues and assure compliance with regulatory requirements and site procedures.
  • Assess criticality of exceptions/investigations for product impact, perform thorough reviews of investigations, and determine potential areas within the process that may have attributed to the exception.
  • Review documents for compliance and identify gaps in existing quality systems, propose solutions, and drive cross-functional improvement initiatives.
  • Collaborate with and/or lead cross-functional teams to execute approved projects aimed at increasing overall quality of business.
  • Mentor and train less experienced associates across Quality Assurance functions, serving as a technical subject matter expert (SME) in support of department functions.
Qualifications
  • Bachelor's Degree required, preferred in Microbiology or life science.
  • Minimum 5 years of relevant Quality experience.
  • Experience working in a pharmaceutical or biotech manufacturing environment.
  • Advanced understanding of global quality systems applications, principles, concepts, practices, and standards and GxP regulations.
  • Excellent written, verbal, and 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, and decisions.
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. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission.

At Biogen, 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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