Cleanroom Quality Specialist

6 days ago

Fermoy, Cork, Ireland beBeeQuality Full time €45,000 - €60,000
Job Overview

The role of a Cleanroom Quality Specialist is pivotal in maintaining the quality standards of Custom Single Run Disposable Containers operations. This position plays a crucial part in supporting the overall quality assurance plan and driving continuous improvement throughout DC Operations.

Key Responsibilities
  • Quality Assurance: Ensure that DC products meet established quality acceptance criteria, focusing on right-first-time production and continuous improvement.
  • Compliance and Documentation: Adhere to Standard Operating Procedures (SOPs) and Guidelines (GDLs), performing in-process inspections and preparing required documentation during manufacturing and packaging.
  • Incoming Material Inspection: Conduct thorough inspections of incoming materials & components, ABEC manufactured items, and assembled systems to ensure conformance to quality standards and related documentation requirements.
  • Quality Documentation: Promote accurate and complete development of quality-related documentation, maintaining a clean and safe working environment.
  • Data Analysis and Improvement: Perform data entry to process accepted materials and components into the ERP system, analyze quality data, and execute improvement plans as assigned.
Required Qualifications
  • Aptitude and Skills: Aptitude with blueprint reading, ability to wear personal protective equipment and cleanroom gowning equipment.
  • Personal Qualities: Self-motivated individual capable of maintaining a clean and safe working space, ability to read tape measure and perform simple mathematical equations.
Experience Requirements
  • Minimum Experience: Minimum one year of relevant experience.
  • Certifications: Certified Quality Inspector (CQI) / Certified Quality Technician (CQT).
  • Manufacturing Background: Experience with GMP manufacturing and documentation.
  • Cleanroom Environment: Background working in an ISO Cleanroom Environment.

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