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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.

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:

• Device Assembly and Packaging Manufacturing

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 Quality Management

• Provides guidance for deviations, observation handling; change control proposals; document creation and revisions.

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

Basic Requirements:

• 3+ years’ experience in Quality pharmaceutical manufacturing required

• 5+ years’ experience in within the pharmaceutical or regulated manufacturing industry

• Bachelors or equivalent degree in a scientific field

Additional Skills/Preferences:

• 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

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

• Ability to work overtime as required

• ASQ Certified

• CSQA (Computer Systems Quality Assurance) 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 others

• 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 around 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.

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

• Ability to work overtime as required

• 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 R1-R3.

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 ( LillyRecruitingCompliance@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.

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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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