Representative - Data Steward QA

Eli Lilly and Company • Indianapolis, IN

10d • $65,250 - $169,400

About The Position

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. Position Title: Representative- Data Steward QA Position Type: Full-Time Pay Grade Level: R1-R4 Location: Indianapolis, LTC-S Job Function: Quality Assurance Supervisor: Associate Director - Site QA and Compliance Position Brand Description: The Representative – QA (QA Data Steward) serves as a power user and data steward for IT systems supported by Quality Assurance. 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.

Requirements

• Proficiency with computer systems including LUNA, Darwin, PMX, SAP, TrackWise, Veeva and RIM.
• Capable of Critical Decision Making while Maintaining a Strong Quality Mindset.
• 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.

Nice To Haves

• 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.

Responsibilities

• Power User for IT systems supported by QA.
• Maintain LIMS System Master Data.
• Quality Management Data Steward in SAP.
• Area Process Owner for IPM Specifications.
• Creates/ Revises Documents, Such as Specifications, Resource Documents, and Procedures.
• Collaborate with Cross-Functional Partners, Such as Operations, TSMS, Engineering, Logistics and QC Labs, to Streamline Processes and Sustain Customer Service.
• Management of Regulatory Updates and Assesses Impact to Specifications and Flavor Management.
• Investigates Non-Conformances and Owns Change Controls to Support.
• Audit Support as Needed.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level