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Quality Representative - Diagnostic Testing Services

Indianapolis, Indiana

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Req ID R-25249 Title Quality Representative - Diagnostic Testing Services City Indianapolis State / Province Indiana Country United States Region Research

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.

At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.

The quality role in Diagnostic Testing Services (DTS) is responsible for the quality system and works collaboratively with the Lilly Quality organization to ensure DTS align with CAP/CLIA and the Lilly Quality System requirements.

Responsibilities:

The DTS function of the Clinical Diagnostic Laboratory (CDL) analyzes diagnostic samples to aid in the diagnosis and treatment of patients. Scientists in DTS validate and implement clinical tests. These clinical tests will be largely 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.

Manages quality functions in DTS

  • CDL Quality Committee Member

  • Facilitates Annual Quality Systems Management Review discussion

  • Supports execution of DTS Quality Plan

Ensures Audit Readiness

  • Develops audit schedule & provides oversight

  • Coordinates audit response and monitors completion.

  • Supports auditing and inspections.

Supports application of Design Control for Diagnostic tests

  • Contribute to potential regulatory filings for diagnostics

  • Provide expertise in 21 CFR 820.30 & ISO 13485

Manages Quality System

  • Supports Lilly Quality representatives with initiating and compliance with various accreditation requirements.

  • Supports execution of Incident and CAPA management program

  • Supports execution of CDL Change Management System

  • Manages DTS Quality system to ensure compliance.

  • Develops and manages Key Performance Indicators (KPI)

  • Tracks and manages trends to improve processes and compliance.

Leader in quality for the DTS function

  • Mentors staff on quality topics

  • Works cross functionally with other groups and LRL Quality representatives

  • Builds consensus for implementation of new regulations/standards across CDL

Technical Understanding

  • Participate in trainings at the bench to ensure appropriate technical knowledge of different instruments/assays in DTS

Basic Requirements:

  • ASCP certified MT/MLS/CLS is required

  • Bachelor’s degree in a core science or equivalent experience.

Additional Skills:

  • Required experience managing quality in a CAP/CLIA laboratory environment.

  • Ability to influence change and implement process improvement.

  • Thrive in grey space and have a solid understanding of quality principles – not just the written guidance.

  • Strong interpersonal, team related excellent communication (written and verbal), skills.

  • Project Management skills.

  • Prior experience successfully implementing the CLIA laboratory

  • Contribute to a collaborative culture of shared learning.

  • Knowledge of implementation and maintaining Computer Systems Validation for instrument controls and software applications.

  • Experience with various assay platforms and multiple computer software applications including LIMS/LIS systems.

  • Bench level experience in Immunoassay and Molecular preferred

  • Knowledge of homebrew assays, Laboratory Developed Tests, Immunohistochemistry is helpful.


Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company.  If you would like to request an accommodation for medical or religious reasons, you may do so at workplace_adjustment@lilly.com. 

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-25249.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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