Lilly Quality Control Laboratory Informatics (Microbiology) in Concord, North Carolina
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.
Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Concord, North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Quality Control Laboratory assures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing.
The QC Laboratory Informatics role is responsible for monitoring laboratory performance to ensure that the QC laboratory maintains within a state of control regarding the generation and reporting of analytical data. Responsibilities will initially involve interacting with global and local IT support functions to populate master data, configure systems, and assist with installing and qualifying laboratory IT systems such as MODA, WinKQCL, LabVantage, Empower, and NuGenesis. The role will evolve into monitoring, execution, maintenance, and continuous improvement of the QC laboratory IT Systems for the QC laboratory with an emphasis on continuous improvement, predominantly focused on data integrity. This role will serve as a representative for the QC laboratory IT systems and will be responsible for mentoring and educating peers on the use of lab systems, supporting audits, and oversight for management reviews, laboratory metrics, and laboratory documentation.
Performs and/or supports the laboratory with validation of laboratory equipment and software systems.
Supports the establishment and maintenance of the validated software-based computerized systems used within the laboratory.
Establishes and ensures data integrity by design within the QC laboratories.
Leads site deployment and upgrade of QC laboratory IT systems.
Partners and builds relationships with Global Quality Laboratory Network and Global IT team members.
Acts as an owner and contact SME for QC laboratory IT systems.
Collects data and authors management review documents for the laboratory quality system.
Provides oversight and supports continuous improvement of quality systems as they relate to the QC laboratories.
Applies knowledge of quality principles, cGMP, and laboratory systems towards the development and execution of local procedures, training courses, and practices.
Assists in improvement of quality systems by creating or revising worksheets, developing or updating laboratory execution system documentation, updating laboratory methods, and maintaining other laboratory documentation systems.
Manages and supports audit and inspection activities for the laboratories.
Performs and mentors personnel in change control, analytical investigations, root cause investigations, and activity planning.
Implements and complies with corporate, site, and laboratory safety standards.
Development of laboratory system training materials.
Bachelor's degree in Computer Science, Information Systems, Chemistry, Microbiology or Biology.
3+ years GMP QC laboratory experience, including leading or working effectively with a cross-functional group.
Deep understanding of compliance requirements and regulatory expectations.
Demonstrated accuracy and proficiency in analytical skills.
Previous technical writing experience.
Proficiency with computer systems including Microsoft Office products, Laboratory Execution Systems.
Ability to work in a laboratory environment, including wearing appropriate PPE and other safety related equipment or considerations.
Previous LEAN experience with the ability to drive continuous improvement.
Experience operating or implementing Laboratory IT systems and other Automated Laboratory Execution systems.
Strong technical aptitude and ability to train and mentor personnel.
Previous project management skills/experience.
Previous experience with cross-function leadership utilizing problem-solving and decision-making skills.
Ability to work 8-hour days, Monday through Friday.
Available off shift to respond to operational issues.
Limited travel may be required during the facility project phase.
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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 (subject to applicable law).