Position Details

Salary $65K – $169K USD / year

Type Full-Time

Experience mid

Exp. Years 0-4+ years

Education Bachelor's degree - Science or Engineering related degree preferred or equivalent work experience

Category Data & Analytics

About this role

Representative - Data Steward QA at Lilly serves as a power user for QA IT systems, maintaining master data, and ensuring regulatory compliance across QA documentation.

Key Responsibilities

Power User for QA IT systems
Maintain LIMS System Master Data
Quality Management Data Steward in SAP
Create/Revise Documents (Specifications, Resource Documents, Procedures)
Collaborate with Operations, TSMS, Engineering, Logistics and QC Labs to streamline processes

Technical Overview

Uses LUNA, Darwin, PMX, SAP, TrackWise, Veeva and RIM to maintain data integrity; performs change controls, non-conformance investigations, and manages regulatory documentation in a cGMP environment.

Ideal Candidate

The ideal candidate is a data steward/QA professional with 2-5 years experience in QA systems, with SAP, TrackWise, Veeva, LIMS, and strong data quality skills; able to communicate with cross-functional teams.

Must-Have Skills

Proficiency with computer systems including LUNADarwinPMXSAPTrackWiseVeeva and RIMCapable of Critical Decision Making while Maintaining a Strong Quality MindsetDemonstrated strong oral and written communication and interpersonal interaction skillsDemonstrated strong technical writing skillsResponsible for maintaining a safe work environmentworking safely and accountable for supporting all HSE Corporate and Site Goals

Nice-to-Have Skills

Experience as a power user or data steward for Darwin or SAPSix Sigma Green Belt Training/ExperienceKnowledge of operations business processessuch as batch dispositionmaterials managementlaboratory specifications and methods

Tools & Platforms

LUNADarwinPMXSAPTrackWiseVeevaRIMLIMS

Required Skills

Proficiency with LUNADarwinPMXSAPTrackWiseVeeva and RIM; strong writing; data governance; cGMP; regulatory updates; change controls; documentation; audit support

Hard Skills

LUNADarwinPMXSAPTrackWiseVeevaRIMLIMScGMPSix Sigma Green Belt (preferred)

Soft Skills

oral and written communicationinterpersonal interactiontechnical writingcritical decision makingteam collaboration

Certifications

Preferred

Six Sigma Green Belt

Industry & Role

Industry Healthcare & Medical

Job Function Serve as a QA data steward and power user for IT systems supporting QA; maintain master data and ensure regulatory compliance

Role Subtype Data Analyst

Tech Domains SQL / PostgreSQL, SAS, Python, R, Hadoop, Spark

Keywords for Your Resume

qa data stewardlunadarwinpmxsaptrackwiseveevarimlimscGMPdata governanceregulatory updateschange controlsspecificationsdocumentationaudit supportquality assuranceregulated dataindianapolissix sigma

Deal Breakers

Lack of degree or equivalent experience, No experience with QA systems (LUNA/Darwin etc.), Poor communication skills

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