Position Details

Type Full-Time

Experience mid

Exp. Years Not specified

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

Category Data & Analytics

About this role

QA data steward role supporting IT systems used by Quality Assurance, focusing on LIMS master data, SAP QA data stewardship, and regulatory compliance.

Key Responsibilities

Power user for IT systems supported by QA
Maintain LIMS Master Data and QA Data Steward in SAP
Area Process Owner for IPM Specifications
Create/Revise documents and procedures
Collaborate with Operations, TSMS, Engineering, Logistics and QC Labs

Technical Overview

Hands-on with LIMS, SAP, TrackWise, Veeva, RIM; governance of QA data; document control and cGMP compliance; strong writing and communication skills.

Ideal Candidate

The ideal candidate is a QA data steward with hands-on experience in QA IT systems (LIMS, SAP, TrackWise) and strong technical writing and communication skills, capable of ensuring regulatory compliance and data integrity in pharmaceutical operations.

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

Required Skills

Bachelor's degree; LUNA; Darwin; PMX; SAP; TrackWise; Veeva; RIM; LIMS; QA systems; cGMP documents; change controls; regulatory compliance; documentation; technical writing

Hard Skills

LUNADarwinPMXSAPTrackWiseVeevaRIMLIMSQA systemscGMP documentschange controlsregulatory compliance

Soft Skills

Critical decision makingStrong oral and written communicationInterpersonal interactionTechnical writing

Certifications

Preferred

Six Sigma Green Belt

Industry & Role

Industry Healthcare & Medical

Job Function QA data governance and regulatory data stewardship for QA IT systems

Role Subtype Data Steward

Tech Domains LIMS, SAP, TrackWise, Veeva, RIM

Keywords for Your Resume

representative data steward qadata stewardqa data stewardlunadarwinpmxsaptrackwiseveevarimlimscgmpgmpregulatory compliancedocumentationtechnical writingipm specificationsbatch dispositionmaterials managementlaboratory specificationsqa

Deal Breakers

Lack of Bachelor's degree in science or engineering or equivalent, Inadequate experience with LIMS, SAP, TrackWise, Veeva, or RIM, Poor communication/technical writing skills

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