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Lilly Quality Assurance Specialist - Parenteral 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 serve an extraordinary purpose. We make a difference for people around the global by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Brand Description:

Lilly is building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina. The Quality Assurance Specialist 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 parenteral areas (preparation, formulation, syringe filling, and visual inspection). The QA Specialist position is essential for ensuring GMP compliance in the design, delivery, verification, qualification, and start up to ensure regulatory approval of the facility by regulatory agencies.

Key Objectives/Deliverables:

  • As project Quality representative, work with Global Facility Delivery, Lilly project staff, and selected A&E firm 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.

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

  • Consult with Network and Global quality groups including the GQS, ETC, GPP and SAT Hub 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 parenteral building, including review of test cases, test execution, discrepancy resolution, etc.

  • 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 Parenteral 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 participation 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 escalate any compliance issues to the project, site, and Quality Management.

Minimum Requirements:

  • Minimum of 5 years of quality knowledge and expertise in parenteral manufacturing.

  • Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation.

  • Previous experience with capital project delivery.

  • Previous experience with parenteral equipment prep, formulation, filling, and visual inspection.

  • Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of parenteral 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 the project team 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

Additional Preferences:

  • ASQ Certified

  • CSQA experience.

  • Previous experience with barrier or isolator technologies

  • Previous experience with Manufacturing Execution Systems.

  • Previous experience with global parenteral platforms (Cartridge, Syringe, or Vial)

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

  • Previous computer system oversight.

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

Education Requirements:

  • Bachelors or equivalent degree in a scientific field

Other Information:

  • Current position is for the 3-4 year design and project delivery phase of the project only. The role will transition into a site quality role at the RTP facility after delivery of the project.

  • Ability to work 8 hour days – Monday through Friday

  • Ability to work overtime as required.

  • Ability to work on a 3 – 6 month short term assignment in Indianapolis, IN.

  • In addition, ability to travel up to 10% to Indianapolis, IN for meetings and coordination within applicable Lilly organizational units.

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.

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 in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.

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!

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