Cleanroom Quality Technician

2 weeks ago

Fermoy, Cork, Ireland ABEC Full time
Overview

Position Title: DC Quality Technician

Reports To: DC Quality Team Leader

Location: Fermoy, Ireland

Job Type: Full-time

Company Background: ABEC has been a leading supplier to the biopharmaceutical manufacturing industry for over 50 years. ABEC's unique 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 Summary: DC Quality Technician follows Custom Single Run (CSR) Disposable Containers (DC) operations procedures and process 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 cross-functional team member within assigned goal-oriented team responsibility.

Responsibilities
  • DC is a right first-time product. The candidate must understand fully the associated quality acceptance criteria and willing to drive for continuous improvement.
  • Ability to 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.
  • Inspection of incoming materials & components, ABEC manufactured items, and assembled systems to ensure conformance to established quality standards and all related quality documentation requirements.
  • Ensure accurate and complete development of all required quality-related documentation.
  • The candidate must be willing to adhere to all associated standards and procedures associated with working in a classified clean environment.
  • Perform necessary data entry to process accepted materials and components into ERP system, conduct associated quality data analysis, and execute the improvement plan.
  • Conduct operations in a safe manner and be fully committed to maintain a clean and safe working environment.
  • Execute other tasks as assigned.
  • Ability to travel when required.
Qualifications
  • Desired attributes:
    • Aptitude with blueprint reading.
    • Ability to wear all personal protective equipment & cleanroom gowning equipment.
    • Self-motivated
    • Must be capable of maintaining a clean and safe working space.
    • Ability to read tape measure and perform simple mathematical equations.
  • Minimum One-year Relevant Experience.
  • Certified Quality Inspector (CQI) / Certified Quality Technician (CQT).
  • Experience with GMP manufacturing and documentation.
  • Experience working in an ISO Cleanroom Environment.
  • Extensive knowledge of industry's legal rules and guidelines.

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