IT Specialist - QC, LIMSNew

Kyowa Kirin, Inc.- U.S. • Sanford, NC

264d • Onsite

About The Position

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario. As a Business Technical Specialist, you will 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). Your responsibilities will include supporting 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. This role will 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.

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.
• Experience with ITSM tools and frameworks.
• Demonstrated independence in diagnosing and resolving complex technical issues.
• In-depth knowledge of troubleshooting methodologies.
• Extensive experience with system administration tasks.
• Strong understanding of security best practices, risk management, and compliance standards.
• Excellent communication and interpersonal skills.
• Ability to manage complex customer inquiries and provide tailored solutions.
• Advanced capability in creating and maintaining detailed technical documentation.
• Experience in generating, analyzing, and presenting actionable technical reports.

Nice To Haves

• Experience with GMP, GDP, and biopharma manufacturing facilities.

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.
• 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.
• Manage 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.

Benefits

• Equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Wholesale Trade Agents and Brokers
• Education Level: Associate degree