Overview
Join to apply for the Cleanroom Quality Technician role at ABEC.
Company Background: ABEC has been a leading supplier to the biopharmaceutical manufacturing industry for over 50 years. ABEC's value is based on combining long experience with the ability to engineer, design, manufacture, commission, qualify, and service the entire bioprocess to reduce overall cost, shorten time to market, and maximise productivity. ABEC's products include process and equipment engineering/consulting services, comprehensive site services, bioreactors and fermenters, filtration and chromatography systems, prep and hold systems, and cleaning/sterilisation systems.
Position Title: DC Quality Technician
Reports To: DC Quality Team Leader
Location: Fermoy, Ireland
Job Type: Full-time
Position Summary
DC Quality Technician follows Custom Single Run (CSR) Disposable Containers (DC) operations procedures and processes to support the overall quality assurance plan. This role supports quality improvement throughout the DC Operations. The technician will execute the required quality steps in manufacturing DCs and have the chance to work in a fast-paced environment on industry leading equipment. This role participates as a cross-functional team member within assigned goal-oriented team responsibility.
Responsibilities
* DC is a right first-time product. Understand fully the associated quality acceptance criteria and drive for continuous improvement.
* Carry out procedures in accordance with Standard Operating Procedures (SOPs) and Guidelines (GDLs).
* Conduct in-process inspections and prepare reporting documents as required during manufacturing and packaging of DCs.
* Inspect incoming materials & components, ABEC manufactured items, and assembled systems to ensure conformance to established quality standards and related quality documentation requirements.
* Ensure accurate and complete development of all required quality-related documentation.
* Adhere to all standards and procedures associated with working in a classified clean environment.
* Perform data entry to process accepted materials and components into the ERP system, conduct quality data analysis, and execute the improvement plan.
* Operate in a safe manner and maintain a clean and safe working environment.
* Execute other tasks as assigned and travel when required.
Qualifications
* O Certified Quality Inspector (CQI) / Certified Quality Technician (CQT) is preferred.
* Experience with GMP manufacturing and documentation.
* Experience working in an ISO Cleanroom Environment.
* Extensive knowledge of industry rules and guidelines.
Desired Attributes
* Aptitude with blueprint reading.
* Ability to wear PPE and cleanroom gowning equipment.
* Self-motivated and capable of maintaining a clean and safe workspace.
* Ability to read tape measure and perform simple mathematical calculations.
* Minimum one year of relevant experience.
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