Sr. Associate III, Quality Assurance (Quality Engineering and Quality Systems)

The Sr. Associate III, Quality Assurance position at Biogen involves a wide range of responsibilities that include developing global quality systems, overseeing GMP activities, and ensuring compliance with all Biogen policies. You will also review essential GMP documentation, proactively identify gaps in quality systems, and engage in collaborative problem-solving with different departments.

To qualify for the Sr. Associate III position at Biogen, a Bachelor's Degree in engineering or a related life sciences field is essential. You need a minimum of 7-10 years of experience in quality within a biotech or pharmaceutical GMP environment, along with expertise in Change Control and a thorough knowledge of global Regulatory Quality requirements.

At Biogen, the work environment for the Sr. Associate III, Quality Assurance is dynamic and collaborative. You'll be part of a mid-sized biotechnology company that values innovation and individual contributions while providing the resources of a well-established business. The emphasis is on teamwork, allowing you to make a significant impact in delivering life-changing medicines.

Biogen is committed to fostering a culture of inclusion and growth for its employees, including those in the Sr. Associate III role. Opportunities for learning and professional development are plentiful, allowing team members to expand their skills while contributing to critical quality initiatives that affect patient lives.

A typical day for a Sr. Associate III in Quality Assurance at Biogen may involve overseeing quality system initiatives, reviewing GMP raw data for compliance, and engaging with different stakeholders to resolve compliance issues. You might also conduct internal and external inspections and participate in monitoring performance systems, all while championing continuous improvement.

In discussing your experience with GMP in a biotech environment, be specific about your roles, responsibilities, and the regulatory standards you adhered to. Highlight any improvements you implemented and how you navigated compliance challenges.

When addressing your strategies for maintaining quality assurance, think about systematic approaches like regular audits, training sessions, and employee involvement. Illustrate this with examples where your strategies directly improved compliance or operational efficiency.

To answer this, describe a specific situation where you identified a discrepancy, your method for investigating it, and the steps you took to rectify it while ensuring compliance. Emphasize the importance of communication and teamwork in your approach.

Emphasize that collaboration is essential in quality assurance. Discuss your experience working with cross-functional teams to implement quality systems and resolve compliance issues, focusing on how collaborative efforts led to better outcomes.

Select a specific quality issue you encountered, focusing on your problem-solving process. Explain how you identified the issue, engaged with stakeholders, proposed a solution, and implemented corrective actions, showcasing your analytical skills.

Discuss your methods for staying informed on regulatory changes, such as subscribing to industry publications, participating in webinars, or attending training sessions. Emphasize the importance of continuous learning in the role of Sr. Associate III.

In this response, outline your preparation process for inspections, including your familiarity with relevant documentation and protocols. Highlight your approach to addressing inspector inquiries and how you promote a culture of compliance among team members.

Be ready to mention specific quality assurance tools or software you've used in your previous roles, like document management systems or quality tracking software, and explain how they enhanced your work efficiency.

Discuss your time management skills and any tools or methods you use to prioritize tasks effectively. Highlight your ability to assess the urgency and importance of tasks and assignments, ensuring quality is never compromised.

When answering this question, connect your personal values with Biogen’s mission. Articulate your passion for the biotechnology industry and how your background and skills align with making a positive impact at Biogen.