Associate - QA Representative - Floor

Associate - QA Representative - Floor Support page is loaded## Associate - QA Representative - Floor Support locations:
US, Concord NCtime type:
Full time posted on:
Posted Todayjob requisition :
R-102188

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:
** Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations.

This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don’t want to miss!
** Position

Description:

** 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 include:

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