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.

The Quality Assurance Representative is responsible for 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.

The QA position is essential for ensuring GMP compliance in the design, delivery, verification, qualification, and start up to ensure regulatory approval of the facility.

As the project progresses, this role will transition to site-based process team supporting one of the following manufacturing areas :

Formulation and Parenteral Manufacturing

Device Assembly and Packaging Manufacturing

Warehouse Logistics

Facility, Utility and Maintenance

Responsibilities :

Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance

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.

Basic Requirements :

Bachelors or equivalent degree in a scientific field

Quality knowledge in pharmaceutical manufacturing required

Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation

Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing

Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills

Ability to work independently as a Quality SME with minimal supervision

Proficiency with computer systems including Microsoft office products, Trackwise, etc.

Responsible for maintaining a safe work environment, working safely & accountable for supporting all HSE Corporate, Project, and Site Goals

Additional Preferences :

ASQ Certified

CSQA experience

Previous experience with manufacturing equipment prep, formulation, filling, and visual inspection, device assembly, packaging, utilities, facilities, maintenance, and warehouse management

Previous experience with Manufacturing Execution Systems.

Previous use of KNEAT or other electronic validation software

Previous technical writing experience

Technical aptitude and ability to train and mentor other

Additional Information :

Ability to work 8-12 hour shifts onsite (not eligible for remote work)

Ability to travel 10-25% or potentially relocate during the project phase to support the design and staffing of the facility

Ability to work overtime as required

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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles.

Our current groups include : Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities.

Learn more about all of our groups.

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Last updated : 2024-05-20