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Senior Quality Associate

2 months ago

Denver, North Carolina, United States Biogen Full time
About the Role

We are seeking a highly skilled and detail-oriented Senior Quality Associate to join our team at Biogen. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our products.

Key Responsibilities
  • Ensure product documentation and other documents supporting batch execution are compliant and determine acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution.
  • Drive exceptions to closure and ensure compliance with procedures and processes, including thorough documented root cause analysis and well-justified rational supports the stated conclusions.
  • Actively monitor applicable data dashboards and collaborate with stakeholders to improve process effectiveness and efficiency.
  • Support Quality Management and Operations staff in the coordination of, preparation for, and follow-up of internal/external audits and inspections as required.
  • Assist QA Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy, and purity of the products manufactured by Biogen.
  • Support and/or assist in GxP quality systems-related training. Provide some mentorship and training within and across functions.
Requirements
  • Bachelor's degree required, preferably in a field of science or biotechnology, or related.
  • A minimum of 4 years relevant technical experience in quality oversight, preferably in a biotech or pharmaceutical manufacturing operation.
  • General understanding of relevant FDA/EMA regulations and compliance.
  • Strong organizational skills.
  • General understanding of Quality concepts; able to practice and implement them.
  • Ability to develop innovative/creative solutions to issues of moderate complexity.
  • Detail-oriented aptitude.
  • Excellent oral and written communication skills.
Preferred Skills
  • Parenteral filling experience strongly desired.
About 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.

Caring Deeply. Achieving Excellence. Changing Lives.

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.