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 Principal Associate - QA Laboratory Support is responsible for demonstrating leadership, teamwork, and quality and regulatory knowledge and oversight to provide guidance, consultation and influence in the design, instrumentation, system and method validation, for startup of the laboratory areas at Lilly's new Concord, North Carolina site. As the project progresses, this role will transition to site-based laboratory process team support for programs such as daily execution oversight and guidance for non-conformance investigations, change control proposals, procedure revisions, and process improvements.
- Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance
- Consult with Network and Global quality groups as required to ensure consistent and compliant approach is executed during the project and startup phase.
- Lead, mentor and coach laboratory personnel on quality matters, including regular presence in the QC Laboratories areas to monitoring GMP programs and quality systems.
- Provide quality oversight for the qualification and validation of the laboratory buildings, systems and instrumentation; including review of test cases, test execution, discrepancy resolution, etc.
- Provide technical and quality review and approval of documents to ensure compliance with Lilly Global Quality Standards and local quality procedures.
- 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.
- Lead project initiatives in support of the project and Quality function
- Resolve or escalate any compliance issues to the project, site, and Quality Management
- Facilitates and coordinates training of new team members, prepares training materials as necessary.
- Provides guidance for deviations, observation handling; change control proposals; document creation and revisions.
Minimum Requirements:
- Bachelors or equivalent degree in a scientific field
- 2 - 3 years of QA or QC experience in pharmaceutical manufacturing (Microbiology experience is required)
Additional Skills/Preferences:
- Commit to successfully maintaining Computer Systems Quality Assurance (CSQA) Certification
- Previous experience with laboratory instrumentation qualification, method transfer and routine product testing
- Demonstrated problem-solving and decision-making skills
- Previous experience supporting or using LIMS and LES systems
- Previous technical writing experience
- Previous facility or area start-up experience
- Technical aptitude and ability to train and mentor others
- Demonstrated knowledge and use of Compendial, 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, accountable for supporting all HSE Corporate, Project, and Site Goals
- Ability to work 8 hour shifts M-F onsite (not eligible for remote work)
- Ability to work overtime as required
- Ability to travel 10-25% to support the design and staffing of the facility.
- 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 ( ) 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.
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.
