Quality Assurance Floor Support Specialist (Night Shift)

JOB DESCRIPTION

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

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (

• ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include : Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$17.30 - $34.38

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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