QCL Stability Admin Tech

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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Responsibilities:

The QC Stability Technician is a technical role in the Quality Control Laboratory helping to ensure the manufacture of products to predetermined standards to meet both Lilly and external requirements by focusing on the oversight of commercial, parenteral product stability studies.  This role is responsible for the planning and coordination of stability studies on all Lilly commercial products manufactured at the RTP site.  The successful candidate will work in partnership with Global QCL, Global IT, Robotics, local site management, and the RTP QC laboratory group to ensure the successful design of facilities to support stability studies and subsequent completion of stability studies for internal trending and external Regulatory reporting. 

Key Responsibilities:

Monitor commercial parenteral product stability studies.

Work with Technical Services Representatives to execute stability protocols and studies utilizing the Laboratory Information Management System (LIMS).

Ensure that modifications to existing stability studies are done according to procedure.

Successfully manage stability studies by running pull reports, collecting samples for testing, submitting samples for testing, and ensuring completion of all testing within procedurally defined times.

Participate in the investigation and provide stability data and graphs to support Manufacturing Investigations.

Periodically reconcile stability sample inventory.

Organize and supply stability data packages to authorized requesters (e.g., Site Regulatory Affairs).

Provide analytical support as needed.

Ensure all aspects of safety are incorporated into the design and practices in the QC Lab stability program, while maintaining a safe work environment, including supporting all HSE Corporate and Site Goals.

Ensure stability procedures and practices adhere to Lilly Global Quality Standards and regulatory requirements, including data integrity.

General sample management and Laboratory Support (E.g. ordering laboratory supplies, performing daily balance check, etc.)

Basic Qualifications/Requirements

High School diploma, preferred Associates or Bachelor's degree in a scientific field related to the laboratory (e.g. chemistry, microbiology or biology)

Additional Preferences:

1+ years GMP Laboratory experience including familiarity with analytical testing.

Previous experience with laboratory IT systems including LIMS, LES, and standalone COTS systems is desired.

Ability to contribute to multiple concurrent project activities and adapt to changes in priorities.

Demonstrated creativity, analytical thinking, and the ability to troubleshoot and solve problems.

Understanding of compliance requirements and regulatory expectations for lab systems.

Excellent written and oral communication skills and ability to collaborate and interact with management, scientists, engineering and IT personnel.

Ability to work 8 hour days – Monday through Friday

Ability to work overtime as required.

Previous experience with stability study planning, management, and execution is desired.

Additional Information:

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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