Position Details

Type Full-Time

Experience lead

Exp. Years 6+ years

Education Bachelor's degree in STEM field

Category QA & Testing

About this role

Manager, Quality Assurance Shop Floor provides 24x7 QA oversight across site operations, ensuring cGMP compliance, BOS/QA processes, and continuous improvement on the manufacturing floor.

Key Responsibilities

Oversee performance of QA shop floor activities
Supervise QA Shop Floor employees
Coach operators and QA personnel
Lead on-the-floor oversight for Manufacturing/QC/Warehouse/Packout/Label Operations
Develop and approve non-routine procedures

Technical Overview

Scope includes QA oversight on manufacturing, QC, warehouse, and packout; requires MES/ERP familiarity, CAPA, deviations, investigations, and on-floor quality control.

Ideal Candidate

The ideal candidate is a seasoned QA leader with 6+ years of cGMP manufacturing experience, strong MES/ERP proficiency, and a track record of CAPA, investigations, and audits. They excel at coaching floor teams and driving continuous improvement in a hybrid Summit West facility.

Must-Have Skills

Bachelor's degree in STEM6+ years of relevant cGMP experience2+ years of QA Shop Floor experienceFDA/EMA regulations knowledgeProject management experience

Nice-to-Have Skills

Experience with MES and ERPQA management experienceAudits and inspections leadershipBiopharmaceutical or cell therapy manufacturing experience

Required Skills

QA shop floor oversightcGMPbatch recordsinvestigationsCAPAchange controlauditsinspectionsMESERPquality management systems

Hard Skills

cGMPQuality AssuranceManufacturing OperationsQuality systemsCAPA managementChange controlInvestigationsDeviationsAudit & inspectionsMESERPAuthorized Person releasePIC/S GMPBatch recordsDocumentation reviewRoot cause analysisTraining and coaching

Soft Skills

LeadershipDecision-makingProblem solvingCommunicationConflict managementPlanning and organizingAnalytical thinkingRelationship building

Industry & Role

Industry Healthcare

Job Function Lead quality assurance on the shop floor to ensure cGMP compliance and continuous improvement across manufacturing operations.

Role Subtype QA Lead

Keywords for Your Resume

quality assurance shop floorcgmpqa shop floormanufacturingmeserpbatch recordsinvestigationsauditsinspectionscapachange controlleadershiptraining and coachingfdaemaquality assuranceCAPA

Deal Breakers

6+ years of cGMP experience, 2+ years QA Shop Floor experience, Hybrid work location Summit West, NJ

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