ICT Business Technical Specialist QC – Lims
| Company | Kyowa Kirin North America |
|---|---|
| Location | Sanford, NC, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | |
| Experience Level | Mid Level |
Requirements
- Expertise in LIMS application processes, specifically LabVantage
- Proficiency in LIMS interfacing, navigation, and customization to streamline workflows and enhance user experience
- Experience in leading projects to conclusion, making recommendations for improved outcomes
- Strong understanding and application of ITIL processes and best practices, with the ability to independently drive continuous improvement initiatives
- Experience with ITSM tools and frameworks, leveraging them to optimize service delivery and align IT support with business needs
- Demonstrated independence in diagnosing and resolving complex technical issues, applying sound judgment and critical thinking to identify root causes and implement effective solutions
- In-depth knowledge of troubleshooting methodologies and the ability to proactively address and mitigate recurring technical challenges
- Extensive experience with system administration tasks, including advanced configuration, performance tuning, and optimization to support business-critical applications
- Strong understanding of security best practices, risk management, and compliance standards, ensuring robust protection of business assets and data
- Excellent communication and interpersonal skills, with a focus on high-level business partnership and aligning IT support with organizational goals
- Ability to manage complex customer inquiries and provide tailored, high-quality solutions that enhance employee experience and business performance
- Advanced capability in creating and maintaining detailed technical documentation, ensuring knowledge sharing and alignment across teams
- Experience in generating, analyzing, and presenting actionable technical reports to senior leadership, contributing to strategic decision-making
- High level of customer service focus, consistently fostering positive employee and business partner relationships, and ensuring a seamless IT experience for all end users
Responsibilities
- Lead the North America & North Carolina manufacturing site ICT team in configuration, implementation, deployment and operational support of manufacturing site’s QC IT applications (i.e. LIMS, ELN & Other Lab Instrument Software and System / Instrument Integrations)
- Support SDLC/ GxP validation activities related to implementation and change controls of QC IT software systems / integrations
- Provide functional / technical expertise on system features, system functionality, access/security controls, master data and understanding of the business processes
- Act as a System Administrator as needed (set up new users and manage security roles)
- Coordinate the needs of QC functional areas and lead LIMS configurations for key business processes in LIMS system related to compliance processes, instrument calibration, quality operations, environment monitoring, CoA, stability testing, vendor compliance, manage inventory, design of queries and report, develop product sampling/test plan
Preferred Qualifications
- At least 3 years of hands-on IT support experience, including troubleshooting complex issues, system management, and working directly with end-users and business partners
- Experience in IT Project Management
- Proven ability to thrive in ambiguous, fast-paced environments; possess a strategic mindset
- Experience with GMP, GDP, and biopharma manufacturing facilities is a plus