Operational Quality Specialist
Core
Provide operational quality oversight at a US manufacturing site to ensure compliance, safety, and reliability of medicines and vaccines production.
Role type
Operational Quality Specialist (Manufacturing)
Builds
Medicines and vaccines for patients
Domain
Biopharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, batch record review and approval, deviation and CAPA management, validation principles, aseptic processing, data integrity (ALCOA+), root cause analysis (DMAIC), regulatory agency compliance (FDA/NIH), quality systems oversight, shopfloor walk-throughs, coaching on quality behaviors
Preferred skills
biologics manufacturing experience, inspection readiness, cross-functional influence, fast-paced environment adaptability, continuous improvement culture
Technologies
robotics, digital solutions, artificial intelligence, GxP systems
Responsibilities
Ensure GMP adherence and inspection readiness; maintain shopfloor oversight and manage initial quality issues; provide real-time guidance to prevent deviations; spot-check production and lab activities; review and approve batch records and GMP documentation; approve deviations, CAPA plans, and change controls; support lot release and self-inspections; coach employees on quality procedures and compliance
Seniority
Mid-level, hands-on IC
