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Lilly Associate - QA Compliance QA for QC in Research Triangle Park, North Carolina

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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe 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 Description:

The QA Representative for the Quality Control Laboratory serves as Quality oversight to provide daily oversight, assistance, and guidance to issues such as non-conformance investigations, change control proposals, procedure revisions, validations, commissioning, and qualification activities. Advise and provide support for other floor support QA Representatives. The QA Representative position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General Inspections by various regulatory agencies.

Responsibilities:

  • Support the QA Compliance team and site in the execution of the site readiness plan with focus on supporting start-up of the QC Laboratory.

  • Approve commissioning/qualification /validation documents for QC Lab computer systems and equipment to ensure compliance with quality standards.

  • Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goals.

  • Lead, mentor, and coach QC Lab personnel on quality matters.

  • Ensure regular presence in QC Lab areas to monitor GMP programs and quality systems.

  • Active member on local Lab team, as outlined in MSOE standard, including participation with Lean Lab initiatives, daily huddle board and continuous improvement.

  • Ability to assess and triage deviations / observations that occur within the local QC Lab team.

  • Work with Lilly support groups and external partners to resolve or provide advice on QC Lab related issues.

  • Participate in self-led inspections and provide support during internal/external regulatory inspections.

  • Ability to effectively review and / or redline documents to ensure quality attributes are met (i.e., deviations / observations, procedures, technical studies, validation protocols, change controls, and engineering documents).

  • Participate in Six Sigma Projects to help improve productivity within the local process team or quality organization.

  • Support project and process improvement initiatives for Lab Teams as representative of the Quality function.

  • Network with Global Parenteral and Device Network sites as resources and benchmarking sources as applicable.

Basic Qualifications:

  • At least 4 years working in the pharmaceutical or medical device industry in QA roles.

  • Previous QC Lab oversight experience.

  • Bachelors degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience.

Additional Skills/Preferences:

  • Previous QC Lab experience.

  • Experience with LIMS, LES, SAP, Veeva Q Docs.

  • Six Sigma Green Belt or Lean Training/Experience.

  • Knowledge of operations business processes, such as batch disposition, materials management, laboratory specifications and methods.

  • Previous equipment qualification and process validation experience.

  • Previous experience with SAP or other inventory management systems.

  • Previous experience with device and parenteral product materials.

  • CQA certification from the American Society for Quality (ASQ)

  • Previous experience with deviation and change management systems including Trackwise

  • Proficiency with GMP computer systems including Lab systems, CAPA systems, and Document Control systems.

  • Demonstrated strong oral and written communication and interpersonal interaction skills

  • Demonstrated strong technical writing skills.

Additional Information:

  • The position is for the Lilly Research Triangle Park site and during the project phase will allow for a flexible working environment with the ability to periodically work remotely based on the project phase and site activities.

  • Must be willing to carry a company cell phone to field off hour quality support to the lab.

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

  • Ability to work overtime as required.

  • Ability to travel up to 5% to Indianapolis, IN for meetings and coordination with global regulatory organizations is required.

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.

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.

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 (subject to applicable law).

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