ICT Business Technical Specialist QC, LIMS

As the ICT Business Technical Specialist QC at Kyowa Kirin, you will lead the ICT team in the North America and North Carolina manufacturing sites, focusing on the configuration, implementation, and operational support of Quality Control IT applications, including LIMS and ELN. Your role may involve validating software systems, managing user access, and overseeing crucial business processes related to compliance and quality operations.

To be considered for the ICT Business Technical Specialist QC position at Kyowa Kirin, candidates should possess an Associate's or Bachelor's degree in Information Technology, Computer Science, or a related field. Additionally, at least three years of IT support experience, particularly in troubleshooting complex issues and system management, is required. Familiarity with biopharma manufacturing facilities and project management experience are also preferred.

In the role of ICT Business Technical Specialist QC at Kyowa Kirin, you play a key part in ensuring quality assurance through the configuration and operational support of QC applications. This includes managing LIMS configurations that affect compliance, instrument calibration, and ongoing quality operations, thereby fostering a environment where best practices are upheld and continuous improvements are sought.

Success in the ICT Business Technical Specialist QC role at Kyowa Kirin hinges on a blend of technical and interpersonal skills. Proficiency in LIMS applications and understanding ITIL processes are crucial, alongside strong communication skills to effectively manage complex customer inquiries and collaborate with various teams. Additionally, your ability to think critically, resolve issues independently, and foster a positive workspace will be key.

The ICT Business Technical Specialist QC role at Kyowa Kirin is fully on-site in Sanford, North Carolina. This position requires you to work directly in the office environment and collaborate closely with team members to ensure effective support for QA operations.

When addressing your experience with LIMS applications during the interview for the ICT Business Technical Specialist QC role, be sure to discuss specific projects where you configured or tailored LIMS to meet business needs. Highlight your familiarity with LabVantage, any customizations you implemented, and the overall impact your contributions had on workflow efficiency and compliance.

Your response should focus on a structured troubleshooting methodology, emphasizing the importance of logical assessment, root-cause analysis, and effective communication. Share an example from your past where you resolved a significant issue, what steps you took, and how you ensured minimal disruption to workflow and compliance.

Discuss your organizational strategies such as prioritization, use of project management tools, and time management techniques. Illustrate with an example where you had to balance multiple tasks successfully, ensuring that quality standards were met without compromising deadlines.

When answering this, draw upon past projects where you were involved in the full software development life cycle (SDLC) and ensure compliance with GxP regulations. Be specific about your responsibilities and how you contributed to maintaining compliance during software implementations or system changes.

Articulate your understanding of security best practices and your experience as a System Administrator. Discuss how you manage user roles, control access levels, and ensure compliance with security protocols to protect sensitive data while providing necessary access to users.

In your response, share a detailed case where you identified an inefficiency in the system and proposed a solution. Explain the rationale behind your recommendation, the implementation process, and the measurable improvements that followed.

Highlight your methodical approach to creating and maintaining technical documentation. Discuss how you focus on clarity, detail, and usability, ensuring that your documentation supports knowledge sharing and alignment across various teams within the organization.

Mention specific resources like professional organizations, webinars, or certification programs you engage with. Discuss how you integrate new learnings and advancements into your work to drive continuous improvement and innovation within QC IT environments.

Emphasize your customer service philosophy, detailing how you first actively listen to the customer's concerns, clarify the issue, perform a thorough investigation, and follow up with tailored solutions while maintaining open lines of communication throughout.

Discuss your motivation to contribute to making a difference in people's lives through pharmaceuticals. Share any personal connections to the industry or previous experiences that fueled your passion for quality control and IT, emphasizing your commitment to continuous learning and growth in this space.