Lilly Associate - Samples & Lab Ops Diagnostic Testing Services in Indianapolis, Indiana
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 35,000 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.
Purpose of the Job:
The Diagnostic Testing Services (DTS) function within the Clinical Diagnostics Laboratory (CDL) analyzes diagnostic samples to aid in the diagnosis and treatment of patients. Scientists in the DTS validate and implement clinical tests. These clinical tests will be Laboratory Developed Tests (LDT) but might also include In Vitro Diagnostics (IVD) approved by regulatory bodies. Data generated might also be used to support regulatory diagnostic submissions.
The Associate - Samples & Lab Ops Diagnostic Testing Services role is in charge for management of clinical samples and the daily operational workflows of laboratory testing for client projects under the CAP/CLIA quality system to diagnose and/or handle patient treatments. The role also provides technical leadership on problem solving, project management, specimen receipt, specimen accessioning, testing order verification, specimen disposals, and equipment maintenance.
This position reports to the Associate Director - Diagnostics Testing Services, Operations.
Key Responsibilities of Job:
Sample Management – Handle all aspects of sample lifecycle. Includes un packaging of samples, sample check-in, quality checks, problem solving, sample distribution, sample tracking, test orders in the Laboratory Information System (LIS), sample destruction and data reporting. Prepping and handling of samples that may also include transferring a sample into other tubes. Function as single point of contact for testing status and communication and result acceptance for data provided to diagnostics partners and regulatory agencies.
Project Management – Will deliver mentorship on project implementation and management of specimens. Assist in managing project prioritization in the lab to meet timelines and expectations. Utilization of computer software such as Excel, Word, Power Point, or other data visualization tools.
Application of Regulatory Requirements – Effectively apply unique diagnostics knowledge and in depth understanding of applicable internal, external, and regulatory requirements/expectations (CAP/CLIA, FDA, and Privacy) for management of samples.
Lab Automation – Will be responsible for supporting and leading LIS entries for sample management and project support. Will supervise all specimens through the workflows from receipt to report to meet DTS needs for effective testing.
Equipment Management and Maintenance - Perform and record regular maintenance and quality checks on freezers and/or equipment as assigned.
Technical writing skills – Responsible for authoring methods, reports, SOPs, and other documentation. Will present order tracking analytics, metrics, and other required information to Leadership and business partners.
Customer Support/Communication –Will be available to provide consultation to DTS clients including assistance with technical issues or testing expectations. Will ensure punctual communication to client on matters related to availability of test results or issues with specimens during receipt or testing. Maintain notebooks in accordance with applicable regulations.
Other specific responsibilities include:
Ensure that each client’s project is set up accurately in the LIS.
Communicate testing priorities and demands to Scientific and Operations staff.
Monitor testing status of each order to ensure on-time patient results.
Handle repeat testing for Scientific staff.
Run test results data within LIS.
Maintain lab supplies inventory including ordering and restocking.
Bachelor’s degree in a science or related life sciences field.
Two years of experience working with healthcare clients and/or clinical lab setting.
Handling, management, and testing of diverse clinical sample types.
Experience managing and working in a clinical laboratory with high efficiency testing.
Demonstrate knowledge of quality principles.
Ability to inspire change and implement process improvement.
Keen eye for detail.
Strong interpersonal and team related skills.
Strong understanding of Project Management tools for querying/tracking or equivalent.
Experience with LIMS/LIS.
Knowledge of Laboratory Developed Tests and/or Immunoassays and Immunohistochemistry.
Proactive, self-sufficient, positive demeanor.
- Location – Indianapolis, Indiana.
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