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.

　　Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Quality Control Laboratory assures patients worldwide of safe and efficacious drug and device products, through effective execution of product testing.

　　The QA Data Steward serves as a power user and quality data steward for IDS systems supported by Quality Assurance including LIMS (Darwin), MES(PMX), SAP, TrackWise, and Veeva Quality Documents. The QA Data Steward is responsible for improving business processes and supporting customer service interactions to ensure key business objectives are met. The QA Data Steward represents Quality Assurance on projects, including lean initiatives. Finally, the QA Data Steward is responsible for activities that include change controls, non-conformance investigations, procedure revisions, impact assessment reviews, Darwin and SAP Master Data creation and approval, review, and approval of cGMP documents, and maintaining regulatory compliance.

　　Key Objectives/Deliverables:

　　Support the QA Compliance team and site in the development and execution of the site readiness plan with focus on supporting startup of new systems and oversight of the site data

　　Power User for IT systems supported by QA including LIMS (Darwin & MODA), SAP, Deviation/Change/Audit (TrackWise), Document Management (Veeva Q Docs)

　　Acts as site Business QA for the QA Data Systems

　　Acts as local training instructor for the QA Data Systems

　　Creates/revises/approves site compliance area documents, including specifications and procedures

　　Collaborates with cross-functional partners, such as Operations, MS&T, Engineering, Logistics and QC Labs, to streamline processes and sustain customer service

　　Investigates non-conformances associated with QA data systems

　　Approves GMP documents (examples: Minor non-conformances, procedures and change controls)

　　Monitors and communicates Site Quality metrics within the site

　　Facilitates Site Quality Metrics reviews within Site Quality Lead Team

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

　　Basic Requirements (Education, Experience, Training):

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

　　Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience

　　Preferred attributes but not required :

　　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.

　　Previous regulatory inspection readiness and inspection execution experience.

　　Previous facility or area start up experience.

　　Experience as a power user or data steward for Darwin, PMX, Kneat, 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 Track wise

　　Additional Information:

　　Ability to work 8 hour days – Monday through Friday

　　May require support outside of regular schedule (weekend days or off-hours) in support of continuous (24/7) manufacturing operations.

　　Ability to travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations.

　　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 ( [email protected] ) 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.

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