Senior Specialist, QA Shop Floor M-F, Cell Therapy
Core
Provide 24x7 quality oversight and compliance monitoring for manufacturing, QC, and warehouse operations in cell therapy production.
Role type
Senior Specialist, Shop Floor Quality Assurance (IC)
Builds
Compliant cell therapy products for patients with serious diseases
Domain
Biopharmaceuticals / Cell Therapy Manufacturing
Required skills
cGMP compliance, GxP record management, deviation investigation, CAPA management, change control, risk assessment, data analytics, process monitoring, clean room observation, procedural documentation, stakeholder negotiation, project management, electronic system proficiency
Preferred skills
FDA/EMA regulatory experience, cell therapy manufacturing experience, STEM degree, Power Automate/Smartsheet/Tableau proficiency
Technologies
SAP, MES, QMS, BMSDocs, CELabs, ValG, DeltaV, Maximo, Infinity, Microsoft Office, Tableau, Smartsheet, Power Automate
Responsibilities
Monitor and track process performance via data and analytics; oversee and approve Floor Quality GxP records (procedures, CAPAs, change controls, deviations); observe manufacturing operations for clean room behavior and aseptic technique compliance; lead area walkthroughs to identify and remediate quality issues; author, review, and approve procedural documents; establish and maintain KPIs and standard work databases; serve as SME for risk assessments and audits.
Seniority
Senior, hands-on IC