Job Description
Seeking a highly skilled Specialist/Lead to provide technical support for electronic systems in a Quality Control Laboratory, ensuring compliance and operational support for laboratory electronic systems.
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to making life better for people around the world. Our employees 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.
The Quality Control Laboratory (QCL) is a critical function within Lilly, responsible for ensuring the quality of our products. The Specialist/Lead will play a key role in supporting the QCL electronic systems, including LIMS and Empower, to ensure compliance and operational support.
Key Responsibilities:
- Provide technical expertise on QCL electronic systems, including LIMS and Empower.
- Work with global functions to develop and deliver standardized processes and procedures for electronic systems in QCL.
- Collaborate with IT, CSV, and Quality departments to ensure QCL Electronic systems are implemented following a development life cycle approach.
- Provide guidance to the laboratory on the configuration and optimal use of electronic systems.
- Provide end-user support for QCL electronic systems, including troubleshooting complex problems.
- Configure master data, worksheets, methods, and reports within the QCL electronic systems.
- Support the authoring and review of key GMP documents, including standard operating procedures and training materials.
- Train other team members on core QC electronic systems.
- Coordinate across business departments and stakeholders to gather and implement enhancement requests for QCL electronic systems.
- Process and support QCL electronic systems change control requests.
- Identify and implement appropriate CAPAs for QCL electronic systems.
- Lead audit requests relating to QCL electronic systems.
- Support the collation of QCL and other departmental metrics from QCL electronic systems.
Basic Requirements:
- Hons Degree Qualified in Chemistry, Microbiology, Information Technology, or related discipline.
- 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.
- Proficient in English.
- Technical expertise in Quality Control applications, including Lab Vantage, MODA, Empower, NuGenesis, and benchtop applications.
- 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 work, with a focus on better, simpler ways and proactive action.
- Learning Agility and Curiosity: High learning agility and flexibility, with the ability to deal with ambiguity and uncertainty.
- Positive Influence: Demonstrated ability to address issues as they arise and take action.
- 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.