Data Steward Lead

3 days ago

Lebanon, Indiana, United States Lilly Full time
About Lilly

Lilly is a global healthcare leader dedicated to making life better for people around the world. Our employees work together 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.

Job Overview

We are seeking a highly skilled Data Steward Lead to join our Quality Assurance team. As a Data Steward Lead, you will be responsible for overseeing critical data maintained within various automated systems, ensuring data integrity, and implementing system changes.

Responsibilities
  • Network with Global quality groups to ensure effective LP2 Site deployment and management of system data.
  • Provide oversight and implement/verify changes of Q-Info Records and Inspection Plans in SAP.
  • Perform change impact analysis, ensure compliant processing of records, system data changes, and performance of system audits.
  • Navigate Veeva/QualityDocs to manage new document routing, metadata for team.
  • Process revisions/creations of specification documents, per approved Change Controls and RCM Matrix revisions.
  • Process revisions/creations of LIMS product, specification, test allocation, and sampling plan master data records.
  • Create/Verify Certificates of Analysis for semi-finished and finished commercial batches as applicable.
  • Support projects/initiatives that may impact data stewardship processes and procedures.
Requirements
  • High School Graduate or equivalent.
  • Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance.
  • Experience working in SAP, Quality Management Systems, and laboratory information management systems.
  • Strict attention to detail and ability to effectively organize/prioritize work and meet critical deadlines.
  • Ability to collaborate cross-functionally with strong written and verbal communication, problem-solving, and crisis management skills.
  • Effective training skills and ability to coach others.
Preferred Qualifications
  • General understanding of laboratory and/or operations techniques and terminology.
  • Previous experience in operations and/or quality control.
  • Previous experience in Veeva/QualityDocs.
  • Proficient in Microsoft Word/Excel/PowerPoint.
Additional Information
  • Ability to work 8-12 hour shifts onsite.
  • During the project phase, this position will allow for a flexible working environment with the ability to periodically work remotely based on the scope and nature of the activities.
  • Position may require travel (10-25%) or potentially a short duration assignment at another Lilly site to establish specific computer system validation and/or data integrity knowledge.

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