Sr. Associate I, Quality Assurance

As a Sr. Associate I in Quality Assurance at Biogen, you will be responsible for reviewing batch records, managing exceptions and investigations, and overseeing QA controlled documentation to ensure compliance with GMP standards. Your role is crucial in maintaining product quality and safety, making detailed assessments of investigations, and collaborating with various departments for effective complaint resolution.

To qualify as a Sr. Associate I in Quality Assurance at Biogen, candidates must possess a Bachelor’s degree in a science discipline along with a minimum of four years of experience in a GMP quality environment specifically in the biotech or pharmaceutical industry. Knowledge of FDA and EMA regulations and excellent organizational skills are also essential for success in this role.

Successful candidates for the Sr. Associate I in Quality Assurance at Biogen should have strong analytical and decision-making skills, a critical thinking mindset, and a collaborative approach to teamwork. An investigative mindset is critical for assessing product impact and resolving deviations, making ability to multi-task and maintain attention to detail vital for success.

Working as a Sr. Associate I in Quality Assurance at Biogen offers a dynamic and collaborative environment where innovation is encouraged. You'll be part of a dedicated team focused on delivering high-quality pharmaceuticals while thriving in an atmosphere that values inclusivity and diverse perspectives. Our mid-sized company culture allows individual contributions to shine, making it a perfect place for personal growth.

Biogen is committed to the development of its employees. As a Sr. Associate I in Quality Assurance, you will have numerous opportunities for professional training, skill enhancement, and career advancement within the organization. Joining Biogen means being part of an innovative team that empowers you to contribute significantly towards transformative medicines and your development.

In your response, highlight specific instances where you successfully reviewed and approved batch records, focusing on your attention to detail and any challenges you overcame during the process.

Discuss your approach to investigating deviations, detailing the steps you take to assess their criticality and your methods for documenting findings and implementing corrective actions.

Demonstrate your knowledge of key regulatory requirements, including specific examples of how you've ensured compliance in your previous roles, as well as any audits or reviews you've participated in.

Share a specific scenario where you successfully worked with cross-functional teams, emphasizing communication skills and problem-solving strategies that led to effective resolutions.

Outline your time management strategies and tools you use to balance multiple tasks while ensuring quality standards are met, and provide an example of how this has worked in your experience.

Discuss any specific QA tools or document management systems you've utilized, focusing on how they have helped you maintain organization and ensure compliance in your work.

Explain your investigation process for analyzing complaints, detailing how you trace potential root causes and work to implement solutions that prevent recurrence.

Give a well-rounded view of how QA professionals contribute to product safety and efficacy, emphasizing your commitment to upholding high standards throughout the product lifecycle.

Mention resources you utilize, such as attending workshops, reading industry-related publications, and networking with peers, to maintain your knowledge of current QA trends and practices.

Highlight your alignment with Biogen's mission, values, and commitment to innovation, along with how your personal career goals resonate with the opportunities the company provides for professional development and making a meaningful impact.