Lead Specialist QC Esystems - Limerick - Eli Lilly and Company

Description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Job Overview

The Lead Specialist QC Esystems role in the Limerick Quality Control Laboratory (QCL) provides technical support for electronic systems within the laboratory. This role will support the QCL electronic systems project implementation, ensure compliance and operational support of laboratory electronic systems associated with all testing activities within the QCL function.

During the startup phase of the Limerick site, the Specialist/Lead will be expected to be a collaborative, inclusive, energetic technical resource in support of the QCL function.

Key Responsibilities

• Key Technical SME on the QCL electronic systems, including but not limited to LIMS and Empower.
• Knowledgeable of general scientific methods in the laboratory and the Esystems that support the laboratory.
• Works with global functions in the development and delivery of standardized processes and procedures for the electronic systems in QCL.
• Primary contact for IT, CSV, and the Quality department ensuring the QCL Electronic systems are implemented following a development life cycle approach.
• Provides guidance to the laboratory on the configuration and optimal use of Esystems.
• Provides end-user support for QCL electronic systems, including troubleshooting complex problems at the application layer within their permission level and escalating as appropriate.
• Configures master data, worksheets, methods, and reports (tabular, trend, and labels) within the QCL electronic systems.
• Supports the Authoring/review of key GMP documents, such as GMP standard operating procedures, training materials, test methods creation documents, local qualification documents, lab/equipment/computer system periodic reviews, annual product reviews, validation master plans, etc.
• Trains other team members on core QC Esystems.
• Coordinates across business departments and stakeholders, gathering, and supporting the implementation of enhancement requests for the QCL electronic systems.
• Processes and supports QCL Esystems Change Control requests.
• Identifies and implements appropriate CAPAs for the QCL Esystems.
• Leads Audit requests relating to QCL Esystems.
• Supports the collation of QCL and other departmental metrics from the QCL Esystems.

Basic Requirements

• Hons Degree Qualified – B.Sc. in Chemistry, Microbiology, Information Technology, or related discipline, with a minimum of 6 years relevant GMP experience.

Additional Skills/Preferences

• Safety first approach to all activities.
• Strong Quality and Data Integrity mindset in a QC environment. Excellent attention to detail.
• Proficient in English.
• Technical expertise in Quality Control applications, e.g., Lab Vantage, MODA, Empower, NuGenesis, and benchtop applications such as DataPro2, SoftMax Pro.
• Highly competent in the use of digital solutions for data, equipment, and laboratory management.
• Experience with regulatory inspections.

Key Attributes

• Business Knowledge: High performance in delivery of their work. Looks at better, simpler ways, takes initiative, and will run proactively with actions. Demonstrated self-management, prioritization, and organizational skills.
• Learning agility and Curiosity: High learning agility and flexibility and ability to deal with ambiguity and uncertainty. Demonstrated ability to identify and prioritize problems, develop, and implement solutions.
• Positive Influence: Demonstrated ability to address issues as they arise and take action. Trusted in the team to follow through on actions. Is interested in own performance and seeks feedback to improve.
• Relationship Builder: Demonstrated ability to establish and maintain key relationships across all levels in the organization.
• Ability to lead people: Demonstrated ability to influence peers and across functions.
• Communication: Demonstrated strong communication skills, written and oral in 1:1 and group situations.
• Decision Making: Demonstrated ability to be decisive and make well-informed decisions for the benefit of the team. Demonstrated ability to collate required information and ask the appropriate questions of peers to get to the best solution.