Description

Quality Technician

Position Summary

The Quality Technician is responsible for the Quality Control activities, monitors production processes, nonconforming products initiatives, implements actions to ensure all finished products compliance with quality standards, customer requirements and regulations. The Quality Tech will report to Director of Quality and Regulatory Affairs and will collaborates with cross-functional teams to identify areas for improvement and drive continuous improvement initiatives.

Duties & Responsibilities

• Perform QC testing and report results; confirm compliance to established requirements
• Perform in-process and final Inspections
• Perform Work Order Closure according to QMS requirements
• Supervise the creation of certificates of analysis [CoA]
• Support on Inventory accuracy and lot traceability procedures
• Lead the Nonconforming Product and related activities [internally and with Vendors]
• Initiate and lead actions to prevent the occurrence of nonconformities relating to product, process, and QMS.
• Report quality and nonconformance data and trends to Quality Manager
• Manage the QC laboratory, consumables, equipment maintenance and calibration
• Support on calibration process of internal devices
• Process Customer Returns, as needed
• Create, revise, and maintain Quality documents, as necessary
• Provide training and guidance to employees on quality control processes, standards, and best practices
• Support on New product design process and be able to discuss / update Product specifications and raw materials, as necessary
• Perform other duties as assigned.

Education

• Technical school or equivalent associate degree
• Technical education or minimum 5 years of cGMP work environmental experience

Skills & Qualifications

• Excellent writing and communication skills
• Proven experience in a QC or QA role, preferably in a manufacturing, cGMP, production or chemistry environment.
• Familiarity with mathematics, statistical analysis tools and techniques for quality improvement
• Organized, proactive approach with the ability to prioritize tasks, work under pressure, and meet deadlines.
• Effectively collaborate with cross-functional teams
• Knowledge of QMS standards, as ISO: 9001 and or ISO:13485, and GMP and FDA regulatory requirements is a plus
• Excellent problem-solving and analytical skills with a keen attention to detail
• MS Office skills

Requirements

• 3 years of Manufacturing / cGMP experience
• Proficient as ERP system user [NetSuite preferred]
• Ability to lift materials and product up to 40 pounds
• Drive license is required
• May require the use of safety PPE or contamination control devices, include but not limited to eye safety glasses, lab coat, hearing protectors, work boots

Qualifications