Quality Assurance Floor Support Specialist (Night Shift)

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!
Responsibilities:
The Quality Assurance Floor Support Specialist is responsible for providing QA oversight to GMP operations. The role will provide QA support of the startup, commissioning and qualification of the Concord site. The QA Floor Support Specialist will demonstrate teamwork by collaborating cross functionally with various levels of the organization. As the project progresses, this role will transition to supporting and escalating issues from manufacturing to the site-based process team for one of the following manufacturing areas:

• Formulation and Parenteral Manufacturing

• Device Assembly and Packaging Manufacturing

• Warehouse Logistics

• Facility, Utility and Maintenance

The key objectives and deliverables for this role are:

• Support on-the-floor manufacturing activities with routine presence in the assigned manufacturing area.

• Follow good documentation practices and compliance with site procedures.

• Review and approve GMP documentation such as electronic batch records, logbooks, etc.

• Troubleshoot and provide support to resolve issues in quality systems such as SAP, LIMS, Trackwise, MES.

• Maintain open communications and promote teamwork in the process team. 

• Support the execution of inspection readiness activities including support of site self-inspections.

• Support project initiatives needed for the project and Quality function.

• Communicate any compliance issues to the project, site, and Quality Management

Basic Requirements:

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

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

• Strong attention to detail

• Ability to work independently with minimal supervision.

• Proficiency with computer systems including Trackwise, SAP etc.

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

• Ability to work a 12-hour Night Shifts onsite on a rotating 2-2-3 schedule (not eligible for remote work)

• Ability to work overtime as required.

• Must pass an annual vision test.

• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment positions on the B or S paths or at levels M1-M2 or P1-P4.

Education Requirements:

• High School diploma or equivalent

Additional Skills/Preferences:

• Associate's degree in a science, engineering, computer, or pharmaceutical related field of study, preferred.

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

• Previous experience with Manufacturing Execution Systems.

• Previous technical writing experience

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.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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