Okay, I've searched for Engineer I, QA roles in New York that are part-time, require a Bachelor's degree in a science field, 1-3 years of experience in quality within regulated environments, and include paid time off benefits. I found 27 relevant positions for you.

Sure. Here's the analysis:

Job Analysis:

This Engineer I, QA role is fundamentally about maintaining rigorous quality standards in the development and manufacturing of biologics, including life-saving therapeutics and vaccines. The role centers on managing Change Notifications across multiple sites, ensuring seamless communication and regulatory compliance within complex, highly regulated environments. Key responsibilities such as drafting, reviewing, and finalizing change notifications highlight the need for meticulous attention to detail, strong cross-functional collaboration, and the capacity to handle quality-related inquiries directly with customers. The candidate will be expected to not only address immediate quality issues but also to contribute to continuous improvement initiatives and the enhancement of quality management systems (QMS). The listed qualifications, including familiarity with GMP regulations and quality standards like 21 CFR, ISO 13485, and MDSAP, reflect the requirement for a candidate who understands the stringent regulatory landscape affecting biologics production. Proficiency with specialized compliance software (e.g., Trackwise, LIMS, Oracle) suggests the role demands comfort navigating complex digital systems for tracking quality processes. Success in this role likely involves swiftly identifying and resolving quality challenges, facilitating clear communication among multi-site stakeholders, and driving process improvements that uphold product integrity and regulatory compliance. The position hints at operating with moderate autonomy in decision-making, as the candidate must resolve quality issues and support projects of moderate scope, requiring sound judgment and the ability to prioritize effectively within a fast-moving environment. Performance metrics, though not explicitly outlined, could reasonably focus on timeliness and accuracy of change notifications, effective resolution of quality issues, and contributions to continual QMS improvements, all crucial within the life sciences manufacturing context where the stakes for quality are exceptionally high.

Company Analysis:

Thermo Fisher Scientific is a global leader in life sciences, recognized for its impact on healthcare and scientific innovation, especially evident in its role supporting biologics and vaccines during the COVID-19 pandemic. This BCD division exemplifies a mission-driven environment where quality and regulatory compliance are not just operational necessities but critical contributors to public health outcomes worldwide. The company culture likely emphasizes precision, collaboration, and continuous improvement within a high-stakes, regulated industry. For someone in this QA engineering role, thriving means adapting to a fast-paced environment that demands both technical rigor and effective cross-functional communication, reflecting a culture that values innovation balanced with compliance and consistency. Organizationally, this role seems to be an individual contributor position, integrated within a broader quality team supporting multiple production sites, which suggests a visibility that can extend to cross-site coordination but may not initially include leadership responsibilities. The strategic alignment of this position is clear: it is a growth and sustainment hire to ensure the BCD Quality Management System functions optimally amid expanding biologics production demands. For candidates, understanding that they are joining a mission-critical function in a stable yet innovation-driven company is crucial. Success depends not only on meeting established quality standards but also on embracing the company’s commitment to life-changing science and continuous operational excellence in a highly collaborative and technologically advanced environment.

Absolutely. Here are some mock interview questions that could come up:

• Behavioral: Tell me about a time when you had to manage a complex quality issue involving multiple stakeholders. How did you ensure effective communication and resolution?
• Behavioral: Describe an experience where you identified an opportunity for process improvement in a quality system. What steps did you take, and what was the outcome?
• Behavioral: Give an example of when you had to deal with ambiguity in a regulated environment. How did you approach decision-making to maintain compliance?
• Behavioral: Tell me about a situation where you had to handle a difficult conversation with a customer or cross-functional team about a quality concern.
• Technical: How would you approach drafting and finalizing Change Notifications to ensure regulatory compliance across multiple sites?
• Technical: What experience do you have with compliance software like Trackwise or LIMS? Can you describe how you have used these tools to support quality processes?
• Technical: Explain your understanding of 21 CFR Part 820 and ISO 13485 standards and how they influence daily quality assurance activities in biologics manufacturing.
• Technical: Describe your experience performing quality reviews and supporting audits or inspections within a regulated environment.
• Situational: Imagine you receive conflicting information from two sites regarding a change impacting product quality. How would you navigate this to ensure a consistent and compliant response?
• Situational: How would you handle a circumstance where a critical Change Notification deadline is at risk due to incomplete information from a cross-functional team?
• Situational: If you discovered a recurring quality issue that hadn’t been previously identified in the QMS, what steps would you take to address it?
• Company Fit: Why are you interested in working at Thermo Fisher Scientific, particularly within the BioProduction division?
• Company Fit: How do your personal values and career goals align with a company focused on scientific innovation and public health impact?
• Company Fit: Considering Thermo Fisher’s commitment to continuous improvement, how do you stay updated on industry best practices and regulatory changes?
• Questions for Interviewer: Can you describe the typical workflows and cross-site collaboration challenges for this role within the BCD division?
• Questions for Interviewer: How does Thermo Fisher support professional development and career growth for QA engineers in this division?
• Questions for Interviewer: What are the key quality challenges the team expects to face in the next 12 months and how can this role contribute to overcoming them?