Lab Informatics Specialist

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

Are you interested in joining our team?

Job Summary

The Lab Informatics Specialist will be responsible for evaluating and improving the Waters NuGenesis system, which is used by the Laboratory Services business unit. The Lab Informatics Specialist will collect and analyze data to then identify and implement effective solutions. This role will develop, configure, and customize the system, while working collaboratively with various departments to understand requirements and maintain data integrity.

On-Site Expectations

• Onsite position (Wilmington, NC or Morrisville, NC), preferred. Remote potential for strong candidates. 
• 1st Shift: Monday - Friday, 8:30am - 5:30pm.

Responsibilities

Data Analysis

• Perform data analysis to support requirements and initiatives.
• Utilize scripts or other advanced programming to explore data and support requests.
• Present data with concise recommendations for resolving simple and complex problems.
• Monitor system health and user adoption post-implementations.
• Understand adverse trends or unusual patterns.
• Evaluate new functionality, interfaces, and modules.

Development, Configuration, and Customization

• Direct projects to gather requirements and develop solutions through configuration updates, interfaces, custom forms, or custom reports.
• Support system upgrades and patches, including impact assessments for customizations.
• Independently lead and/or manage medium to large projects and project teams.
• Participate in validation activities and provide subject matter expert support during change management processes.
• Configure NuGenesis SDMS, LMS, and ELN, manage installations, and integrate with lab instruments and chromatography data systems.
• Define roles, set access controls, and implement security measures to ensure regulatory compliance.
• Configure workflows, customize ELN templates, automate data capture, and establish retention policies.
• Configure APIs and middleware for seamless integration with LMS, SAP, and other enterprise systems.

End User Support

• Serve as a liaison between end users, leaders, IT team, and vendor.
• Author operational and administrative procedures, instructions, and knowledge base articles to ensure effective systems operations.
• Support escalated help requests via ticket system in a courteous professional manner.
• Trouble-shoot and resolve technical challenges and unexpected behavior without relying heavily on the vendor.
• Triage and escalate problems when required.
• Provide exceptional customer service and follow up on incidents and issues when needed.
• Other duties as assigned.

Qualifications

• Bachelor's Degree in Computer Science or related field required, or equivalent experience.
• 2+ years’ experience supporting Waters NuGenesis LMS version 9, including ELN Smart Builder forms, JasperReports, and SDK.
• 4+ years of experience in a GxP regulated setting.
• Experience using or supporting laboratory/scientific software systems and processes preferred.
• Experience with RESTful/SOAP APIs and scripting for lab instrument connectivity is highly desirable.

Knowledge, Skills, and Abilities

• Extensive understanding of NuGenesis LMS configuration and logs.
• Proficiency in Smart Builder and JasperReports
• Strong knowledge of SQL database management and scripting.
• Expertise in SQL, VBScript, PowerShell and XML, with additional knowledge of Python, C#/.NET, and JavaScript for automation, integration, and customization.
• Strong analytical and problem-solving skills with attention to detail and accuracy.
• Understanding of virtual clients such as VMware, Citrix, etc.
• Exceptional written and oral communication skills.
• Excellent interpersonal skills, with a focus on rapport-building, listening, and questioning skills.
• Ability to learn quickly and provide end user support.
• Familiarity with software development lifecycle and GAMP 5 guidelines.

Travel Expectations

• Less than 5% travel expected.

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met or encountered by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit. The employee is occasionally required to stand, use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is occasionally required to walk; climb or balance and stoop, kneel, crouch, or crawl. The noise level in the work environment is usually moderate. The employee may be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, lab coats, etc.