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Delcath Systems · 4 hours ago

Quality Assurance Technician

Queensbury, NY

Full-time

Onsite

New Grad, Entry Level

Delcath Systems is focused on maintaining a compliant quality system, and they are seeking a Quality Assurance Technician to support this goal. The role involves monitoring manufacturing processes, performing inspections, and ensuring compliance with FDA and ISO regulations.

BiotechnologyHealth CareOncologyPharmaceutical

H1B Sponsor Likely

Responsibilities

Responsible for monitoring and confirming manufacturing process activities

Review/issue DHR’s to support Manufacturing operations

Perform/review line clearance activities to support Manufacturing operations

Responsible for reviewing manufacturing records and verifying data

Perform in-process inspection of medical devices and device components

Perform final product inspection and final release activities

Responsible for organizing and performing Incoming Inspection duties

Responsible for performing environmental monitoring testing, organizing data and creating reports

Assist with supplier corrective actions and nonconforming material reports

Support and participate in quality investigations under supervision

Maintain accurate records in accordance with GMP/GDP requirements

Assist with verification and validation testing activities

Assist during internal and external audits by preparing records and responding to quality requests

Other duties as assigned

Qualification

FDA complianceISO regulationsGMP/GDP requirementsIn-process inspectionEnvironmental monitoringQuality investigationsData organizationSupplier corrective actions

Required

Responsible for monitoring and confirming manufacturing process activities

Review/issue DHR's to support Manufacturing operations