Sr. Associate III, Quality Control - Microbiology

The primary responsibilities of the Sr. Associate III, Quality Control - Microbiology at Biogen include overseeing laboratory investigation systems, managing change control compliance, and supporting the microbial identification program. Additionally, you'll be involved in ensuring the quality of manufacturing batch production and maintaining the laboratory in an audit-ready state, all while working collaboratively within a cross-functional team.

To qualify for the Sr. Associate III, Quality Control - Microbiology role at Biogen, you should hold a Bachelor’s Degree in a life sciences-related field, with 7-10 years of experience in a Quality Control role within a GMP environment. Experience in microbiology, particularly in bioburden and endotoxin assays, as well as demonstrated project management skills, is essential for success in this position.

Preferred skills for the Sr. Associate III, Quality Control - Microbiology position at Biogen include experience with Laboratory Information Management Systems (LIMS) such as LabWare, familiarity with TrackWise, and knowledge of Product Lifecycle Management (PLM). These skills can enhance your ability to effectively manage laboratory processes and quality control initiatives.

Biogen promotes a culture of inclusion through its commitment to valuing diverse backgrounds and perspectives. For the Sr. Associate III, Quality Control - Microbiology role, you'll be part of a team that embraces diversity, ensuring that all employees contribute their unique views and experiences. This culture enhances innovation and teamwork, making Biogen a great place to grow your career.

The work environment for the Sr. Associate III, Quality Control - Microbiology at Biogen is collaborative and engaging, providing opportunities to work with talented individuals who are passionate about delivering life-changing medicines. The position is full-time and on-site, allowing you to immerse yourself in the team culture and contribute to meaningful projects that impact patient lives.

When answering this question, highlight specific experiences related to microbial identification projects you've handled, the methods you employed, and how these experiences contributed to product quality. Mention any relevant techniques like PCR or culture methods and emphasize your ability to address challenges in this area.

To effectively answer this question, discuss your project management skills, including tools you use for prioritization and organization. Provide examples of past projects and how you ensured deadlines were met, demonstrating your ability to maintain high quality under pressure.

In your response, narrate a specific scenario where you detected a deviation, outlining the investigation process you followed. Describe how you collaborated with team members to resolve the issue and the protocols you implemented to prevent future occurrences.

Discuss specific strategies you've implemented to maintain compliance, such as regular audits, staff training, and active participation in quality control reviews. Highlight the importance of communication within teams and how these strategies helped improve compliance rates.

Answer by detailing the practices you follow, such as maintaining thorough documentation, regular equipment calibration, and staff training. Provide examples of how you anticipate audit requirements and proactively address any gaps before they are identified during an actual audit.

Focus on your data review processes, emphasizing accuracy and attention to detail. Discuss specific types of data you've reviewed, any statistical analysis methods you utilized, and how your reviews contributed to the overall quality management process.

Mention specific quality control tools or software, such as laboratory management systems (LIMS) or change control software. Explain how you've utilized these tools to streamline processes, manage compliance, and any challenges you faced with their implementation.

Discuss how you assess urgency and importance when prioritizing tasks. Provide examples from past experiences where you successfully managed competing priorities and the method you used to keep track of your workload while remaining productive.

Share a specific quality improvement project you were involved in, detailing your role, the measures implemented, and the outcomes achieved. Emphasize your problem-solving skills and collaboration with others to enhance quality within the laboratory.

In your answer, express your passion for ensuring product quality and safety, citing particular aspects of working in biotechnology that inspire you. Discuss your commitment to improving patient outcomes and how this aligns with Biogen's mission.