Position Details

Salary $65K – $169K USD / year

Type Full-Time

Experience entry

Exp. Years 3+ years

Education BS in Engineering or science related field

Category Data & Analytics

About this role

Associate - QA Master Data Steward acting as a data steward in SAP and LIMS for specifications at Lilly's Lebanon API site. Develop and oversee the specification program, manage master data, support change controls and deviations, and participate in regulatory inspections while liaising with US and OUS customers.

Key Responsibilities

Develop and provide oversight to the Specification program
Manage master data in SAP and LIMS at startup and routine manufacturing
Support data management for change controls and deviations
Prepare for and participate in internal and external regulatory inspections
Acts as a liaison for US and OUS customers toward resolution of concerns

Technical Overview

Role centers on SAP/LIMS master data management for GMP manufacturing, with familiarity in QA, cGMPs, regulatory inspections, and root cause investigations.

Ideal Candidate

An entry-level QA Master Data Steward with 3+ years in pharma, skilled in SAP and LIMS master data management, specifications, cGMP awareness, and regulatory inspection readiness; capable of coordinating data for startup GMP manufacturing and liaising with US and OUS customers.

Must-Have Skills

BS in Engineering or science related field3+ years in pharmaceutical industryAuthorized to work in the United States on a full-time basis

Nice-to-Have Skills

Previous experience in pharmaceutical industryPrevious experience in QATS/MS QC or EngineeringPrior work with cGMPs or external regulationsPrevious experience with root cause investigations

Tools & Platforms

SAPLIMS

Required Skills

Master Data ManagementSAPLIMSSpecification programGQS guidelinesdata stewardQAcGMPsroot cause investigationsregulatory inspections

Hard Skills

SAPLIMSMaster Data ManagementSpecification managementGQS guidelinesQAcGMPsRoot cause investigationsRegulatory inspectionsData stewardQuality AssuranceUS and OUS customers liaison

Soft Skills

CommunicationInterpersonal skillsAttention to detailRegulatory readinessProblem-solving

Industry & Role

Industry Healthcare & Medical

Job Function Data steward for SAP and LIMS master data to support GMP manufacturing specifications

Role Subtype Data Steward

Tech Domains SAP, LIMS, Security & Compliance

Keywords for Your Resume

SAPLIMSMaster Data ManagementSpecification programGQS guidelinesQAcGMPsRoot cause investigationsRegulatory inspectionspharmaceutical industryauthorized to work in the United Statesdata stewardUS and OUS customerschange controls and deviationsgpmssaplimsmaster data managementspecification programgqs guidelinesqacgmproot cause investigationsregulatory inspections

Deal Breakers

Not authorized to work in the United States, Less than 3 years in pharmaceutical industry, No SAP or LIMS experience

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