Eli Lilly and Company · 9 hours ago
Quality Representative - Floor Support Parenteral
Concord, NC
Full-time
Onsite
Mid Level
$65K/yr - $169K/yrEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to discovering and delivering life-changing medicines. The Quality Assurance Representative will provide leadership and oversight in ensuring GMP compliance during the design and startup of manufacturing areas, with responsibilities including quality oversight and support for the development of site quality operations.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Demonstrating leadership, teamwork, and quality and regulatory knowledge and oversight to provide guidance, consultation and influence in the design, verification, and startup of the manufacturing areas at Lilly’s new Concord, North Carolina site
Act as a cGMP liaison, working with Global Facility Delivery and Lilly project staff to complete the detailed design of the assigned areas employing QbD and QRM principals and ensuring the integration of Global Quality System requirements into the design
Consult with Network and Global quality groups as required to ensure consistent and compliant approach is executed during the project and startup phase
Actively participate in required design reviews and final design qualification activities
Provide technical and quality review and approval of project documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures
Provide quality oversight for the verification and qualification of the manufacturing buildings, including review of test cases, test execution, discrepancy resolution, etc
Work with the Site Quality Leadership to support the development of the vision and strategy for the overall site quality operation and cross-functional support with focus on the Manufacturing areas
Support the site organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, including mentoring and training of new Quality and other project staff
Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
Support the definition and execution of inspection readiness activities including support of site self-inspections in GQA
Lead project initiatives needed in support of the project and Quality function
Resolve or escalate any compliance issues to the project, site, and Quality Management
Provides guidance for deviations, observation handling; change control proposals; document creation and revisions
Qualification
Required
Bachelors degree
Quality knowledge in pharmaceutical manufacturing required
Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation
Proficiency with computer systems including Microsoft office products, Trackwise
Preferred
ASQ Certified
CSQA experience
Previous experience with manufacturing equipment prep, formulation, filling, and visual inspection
Previous experience with Manufacturing Execution Systems
Previous use of KNEAT – or other electronic validation software
Previous technical writing experience
Benefits
Company bonus (depending, in part, on company and individual performance)
401(k)
Pension
Vacation benefits
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.
Founded in 1876
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
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2026-01-25
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