Job DetailsAt 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 using quality/regulatory knowledge and oversight to provide guidance, consultation and influence in the design, verification, and startup of the manufacturing operations at Lilly's new Concord, North Carolina site. The QA Representative's demonstration of leadership and cross-functional teamwork is essential for ensuring a constant state of cGMP compliance, as well as ensuring regulatory approval of the Concord facility through all design, delivery, verification, qualification, and startup activities. As the site's startup project progresses, the QA Representative will continue to directly support the Device Assembly and Packaging (DAP) manufacturing areas.
Responsibilities include:- Maintains knowledge of Current Good Manufacturing Practices (cGMP), including good documentation practices (GDP), data integrity and regulatory compliance
- Fosters a strong quality culture by maintaining open communication, promoting teamwork and encouraging employee participation in the working group
- Guides others in Quality Management System (QMS) topics such as exceptions, observations, deviations, corrective action/preventive action (CAPA), change controls, document creation/revisions, etc.
- Supports the definition and execution of inspection readiness activities including support of site self-inspections
- Resolves or escalates any compliance issues to the project, site and Quality Management
- Functions 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 principles and ensuring the integration of Global Quality System requirements into the design
- Consults with Network and Global Quality groups to ensure a consistent and compliant approach is executed during the startup phase
- Actively participates in required design reviews and final design qualification activities
- Provides technical and quality review/approval of project documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures
- Provides quality oversight for the verification and qualification of the manufacturing buildings, including review of test cases, test execution, discrepancy resolution, etc.
- Works 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
- Supports 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
- Leads project initiatives needed in support of the startup project and Quality function
- Maintains a safe work environment, working safely & accountable for supporting all HSE Corporate, Project, and Site Goals
Basic Requirements:- Bachelor's or equivalent degree in a scientific field
- Ability to work 12-hour shifts on a 2-2-3 production schedule, with additional hours when required
- Ability to work onsite in Concord, NC (not eligible for remote work)
Additional Skills/Preferences:- Experience within the pharmaceutical, medical device, or other regulated manufacturing industry preferred
- Experience as a Quality professional supporting pharmaceutical and/or medical device manufacturing preferred
- Knowledge and use of US, EU, Japan and other regulations in pharmaceutical manufacturing
- 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.
- ASQ Certification
- CSQA (Computer Systems Quality Assurance) experience
- Experience with manufacturing equipment preparation, formulation, filling, visual inspection, device assembly, packaging, utilities, facilities, maintenance, and warehouse management
- Experience with Manufacturing Execution Systems.
- Use of KNEAT - or other electronic validation software
- Technical writing and review experience
- Technical aptitude and ability to train/mentor others
- Experience with C&Q/Verification and Validation oversight including automation and computer systems validation
- 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.
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