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Lilly Quality Assurance Data Specialist in Indianapolis, Indiana

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:

For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

Position Brand Description:

The Representative – QA (QA Data Steward) serves as a power user and data steward for IT systems supported by Quality Assurance including Darwin, PMX, SAP, TrackWise, Regulus and Certificate of Analysis management. The Representative – QA (QA Data Steward) is responsible for improving business processes and supporting customer service interactions to ensure key business objectives are met. Representative – QA (QA Data Steward) represents Quality Assurance on projects, including six sigma. The Representative – QA (QA Data Steward) is responsible for activities that include change controls, non-conformance investigations, procedure revisions, impact assessment reviews, creation and revision of specifications, review and approval of cGMP documents, and maintaining regulatory compliance.

Key Objectives/Deliverables:

  • Power User for IT systems supported by QA (Darwin, PMX, SAP, TrackWise, Regulus).

  • Creates/revises documents, such as 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.

  • Approves GMP documents (examples: L1 non-conformances, procedures and L1 change controls).

Additional Preferences:

  • Proficiency with computer systems including Darwin, PMX, SAP, TrackWise, and Regulus

  • Demonstrated strong oral and written communication and interpersonal interaction skills

  • Demonstrated strong technical writing skills

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

  • Experience as a power user or data steward for Darwin or SAP.

  • Six Sigma Green Belt Training/Experience.

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

Education Requirements:

  • Bachelor’s degree – Science or Engineering related degree

Other Information:

  • Overtime may be required.

  • Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant. Mobility requirements and exposure to allergens should be considered when applying for this position.

  • Minimal travel required.

  • May be subject to Post Offer Exam.

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.

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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