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Lilly Senior QA Representative - Device and Packaging - Project in United States

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 35,000 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.

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 39,000 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. #WeAreLilly

Position Brand Description:

Lilly is building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina. The Senior 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 Device, Packaging, and Warehouse areas. This position is essential for ensuring GMP compliance in the design, delivery, start up to ensure regulatory approval of the facility by regulatory agencies.

Key Objectives/Deliverables:

  • Act as a cGMP expert, working with Global Facility Delivery, Lilly project staff, and A&E firm to complete the detailed design of the assigned areas employing Quality by Design and Quality Risk Management principals and ensuring the integration of Global Quality System requirements into the design, verification, validation, and start up.

  • Interact with the other global, project and functional areas to coordinate design and start up activities to support the overall project and site schedule.

  • Collaborate with Network and Global quality groups as required to ensure consistent and compliant approach is carried out during the project and startup phase.

  • Actively play a part 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.

  • Work with the Site Quality Leader to support the development of the vision and strategy for the overall site quality operation with focus on the Device, Packaging, and Warehouse 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 of new Quality and other project staff.

  • Foster a strong quality culture including maintaining open communications and promoting teamwork and employee engagement in the work group.

  • Support the definition and execution of inspection readiness activities.

  • Lead project initiatives needed in support of the project and Quality function.

  • Resolve or communicate upward any compliance issues to the project, site, and Quality Management.

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

Minimum Requirements:

  • At least 10 years combined of pharmaceutical, medical device assembly, and/or pharmaceutical packaging experience in manufacturing and quality

  • Previous experience with Commissioning & Qualification, Verification, and Validation oversight.

Additional Preferences:

  • Experience in medical device assemble and/or packaging manufacturing and quality.

  • Previous quality knowledge and oversight of warehouse operations.

  • Previous experience with capital project delivery.

  • Previous experience with Manufacturing Execution Systems

  • Previous experience with SAP

  • Previous experience with automated warehousing, incoming receipt and release processes.

  • Previous use of KNEAT – or other electronic validation software.

  • Previous computer system oversight.

  • Strong technical aptitude and ability to train and mentor others.

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

  • Ability to work independently as a Quality SME with the project team with minimal supervision.

  • Proficiency with computer systems including Microsoft office products, Trackwise, etc.

Education Requirements:

  • Bachelors or equivalent degree in an engineering or scientific field

Other Information:

  • Internal Candidates - Contact hiring manager before applying.

  • Tasks may require repetitive motion (e.g., keyboarding).

  • Ability to work 8 hour days – Monday through Friday required

  • Ability to work overtime as required.

  • Available off shift to respond to operational issues as needed is required

  • Ability to travel up to 50% of the time or potentially relocate during the project phase to support the design and startup of the facility.

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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at workplace_adjustment@lilly.com.

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

#WeAreLilly

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