Senior Associate I, Quality Assurance Specialist

2 weeks ago

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

We are seeking a highly skilled and detail-oriented Senior Associate I, Quality Assurance Specialist 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
  • Batch Record Review and Compliance: Conduct thorough reviews of quality-related documents, including production records, procedures, and raw data, to ensure compliance with regulatory requirements and company directives.
  • Exceptions and CAPA Management: Assess the criticality of exceptions and investigations, perform thorough reviews, and provide feedback to department owners. Support investigations with the ability to analyze defects and determine potential areas within the process that may have contributed to the defect.
  • Controlled Document Workflows: Review GMP controlled documents to ensure changes and reasons are accurately reflected in the workflow, content is compliant with all applicable regulations and company directives, and changes will not have an adverse impact on product quality.
  • Technical Writing and Investigation Support: Execute activities including technical writing, investigation support (root cause analysis/impact assessment), and project representation.
  • Quality Systems and Compliance: Support the resolution of technical and compliance issues/gaps of moderate complexity, help implement Quality Systems/System Improvements, and provide technical problem-solving support.
  • Quality Management Systems: Assist Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, ensuring the safety, efficacy, and purity of the products manufactured by Biogen.
  • Equipment Control and Release: Control and release of equipment from maintenance, validation, change control, and product changeover.
  • GxP Quality Systems-Related Training: Support and/or assist in GxP quality systems-related training, provide mentorship and training within and across functions.
Requirements
  • Education: Bachelor's degree in a field of science or biotechnology.
  • Experience: Minimum of 4 years of relevant technical experience in quality oversight, preferably in a biotech or pharmaceutical manufacturing operation.
  • Regulatory Knowledge: General understanding of relevant FDA/EMA regulations and compliance.
  • Manufacturing Process Knowledge: General understanding of the manufacturing process.
  • Organizational Skills: Strong organizational skills.
  • Quality Concepts: General understanding of Quality concepts; able to practice and implement them.
  • Problem-Solving Skills: Ability to develop innovative/creative solutions to issues of moderate complexity.
  • Communication Skills: Excellent oral and written communication skills.
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.

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