Eli Lilly and Company · 15 hours ago
Scientist - Quality Assurance
Durham, NC
Full-time
Onsite
Mid, Senior Level
$65K/yr - $169K/yr
5+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. They are seeking an experienced Quality Assurance Scientist to support their growth in a state-of-the-art facility in Research Triangle Park. The role involves ensuring quality oversight of site activities, maintaining GMP compliance, and providing support during regulatory inspections.
BiotechnologyHealthcarePharmaceuticalHealth CareMedical
Responsibilities
Support the site in the development and execution of the site readiness plan with focus on supporting operations process and startup of new systems
Effectively review/approve GMP documents to ensure quality attributes are met (i.e.: Non-conformances, procedures, protocols, specifications, and change controls)
Active on local process teams or indirect participation through project support activities
Lead, mentor, and coach operations and support personnel on quality matters
Ability to assess and triage deviations / observations that occur within Drug product formulation, filling and visual inspection processes
Provides guidance in operational areas to ensure robust Quality Systems and GMP compliance
Support project and process improvement initiatives for Plant Process Teams as representative of the Quality function
As applicable, approve commissioning qualification / validation documents for equipment to ensure compliance with quality standards
Liaison with Lilly support groups and external partners to resolve or provide advice on product related issues
Participate in self-led inspections and provide support during internal / external regulatory inspections
Responsible for adhering to safety rules and maintaining a safe work environment for yourself and others by supporting HSE corporate and site goals
Qualification
Required
Bachelor's degree
Preferred
Minimum of 5 years of demonstrated experience in GMP facility
Demonstrate knowledge and understanding of aseptic manufacturing process, isolator technology, visual inspection, and Quality Systems
Ability to make technical decisions, provide guidance to the site and lead others
Demonstrated strong oral and written communication skills, interpersonal skills and ability to work as a team
Root cause analysis/troubleshooting skills
Demonstrated attention to detail and ability to maintain quality systems
Previous regulatory inspection readiness and inspection execution experience
Proficiency with Manufacturing Execution Systems (PMX or similar), Inventory Management Systems (SAP or similar), Laboratory Information Management System (LIMS), Deviation Management Systems (TrackWise), Change Management
CQA certification from the American Society for Quality (ASQ) or CSQA Experience
Proficiency with computer systems including Microsoft office products
Proven ability to work independently or as part of a team to resolve issues
Benefits
Company-sponsored 401(k)
Pension
Vacation benefits
Eligibility for medical, dental, vision and prescription drug benefits
Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
Life insurance and death benefits
Certain time off and leave of absence benefits
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
2026-02-09
2026-02-09
Company data provided by crunchbase