Eli Lilly and Company · 2 days ago
Sr. Associate – QA Distribution
Plainfield, IN
Full-time
Onsite
Mid, Senior Level
$65K/yr - $148K/yr
3+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving lives through discovery. The QA Distribution Associate provides quality oversight of the distribution of commercial material, ensuring compliance with regulations and guidelines while collaborating with various teams to enhance operational quality and efficiency.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Make quality culture the foundation of your work, to ensure our products are delivered on time and in safe and effective manner to improve patients’ lives
Collaborate with site compliance leader and site data integrity leader to ensure robust Quality System and Computer Systems in full compliance with regulations and data integrity requirements
Understand NALO Operations to be able to provide quality oversight, identify and escalate potential Quality concerns, support meeting business goals and lead process improvement initiatives
Support engineering and provide Quality oversight to FUME activities and projects
Provide Quality oversight for NALO distribution operations network and maintain a state of inspection readiness for all distribution warehouses under NALO control. Support development of quality indicators/metrics to track Quality performance at all distribution locations
Collaborate both internally and externally to identify opportunities to standardize operations, increase global harmonization, and identify improvement opportunities
Apply Quality Risk Management principles to NALO operations, using Lilly quality standards. Author and review and approve Risk Assessments to ensure adequate oversight including external monitoring of regulatory changes
Provide quality oversight and maintain the qualified status of distribution supplier and service provider per Supplier Quality Management System
Manage, investigate and document product and distribution complaint and monitor performance
Author, review and approve quality documents such as deviation investigations, change control activities, CARTS, PPE, SCN’s, SOP …etc, with focus on issue resolution and continuous improvement
Develop and collect metrics related to the Quality performance within area of responsibilities. Provide updates to management and propose performance improvement
Support inspection readiness initiative and internal/external audits (site self-inspections; regulatory agencies and GQAAC)
Support the Operations by:
Timely and accurately completing all assigned tasks and responsibilities
Collaborate with other functions, including hands-on work experience and shared learning
Propose solution and Benchmarking with other Lilly sites to gain support
Other duties as assigned
Qualification
Required
Bachelor's degree in Engineering, Pharmacy, Chemistry, Life Sciences, Supply Chain/Logistics, or related field
3+ years of Engineering and/or QA experience supporting distribution in the pharmaceutical industry
Preferred
Prior Quality or engineering experience working in Distribution, Medical Devices and providing oversite to 3PLs and Service Providers
Prior FUME experience and understanding FUME requirements and regulations
Knowledge and experience with CSQA and Data Integrity application
Experience with ICH Q9 and/or Lilly's Quality Risk Management standards
Clear understanding of all GMP/GDPs, policies, procedures, regulations and guidelines related to commercial distribution
Knowledge and experience in quality records (Deviation, CC, PPE, SCN's, procedure…etc)
Effective communication both written and oral
Demonstrated ability to be self-driven, work independently, and apply time management and project management skills
High-quality skills to include ability to prioritize, critical decision making, interpersonal/people, problem solving
Strategic thinking and ability to influence diverse groups and communicate effectively to all levels of an organization internally and externally
Strive to exceed individuals and business goals and continuous improvement
Benefits
Company bonus (depending, in part, on company and individual performance)
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
Fierce Healthcare
2026-02-07
Company data provided by crunchbase