Microbiologist - Quality Assurance Specialist

3 hours ago

Dublin, Dublin City, Ireland beBeeQuality Full time €40,000 - €60,000

Microbiologist - Quality Assurance Specialist

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We are seeking a highly skilled Microbiologist - Quality Assurance Specialist to join our team in Dublin, Ireland. As a key member of our quality assurance department, you will be responsible for ensuring the highest standards of microbiological quality in our large-scale facility.

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About the Role:

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This is an exciting opportunity to work on a €1 billion project, where you will have the chance to learn new technologies and develop your current skills in a fast-paced environment. You will be part of a collaborative team that values innovation and excellence.

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Responsibilities:

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  • Cleanroom monitoring: Perform regular monitoring of cleanrooms, BSCs, and isolators to ensure optimal conditions for microbial growth.
  • Utility sampling: Collect and analyze samples from water systems, compressed air, and gas to ensure compliance with regulatory requirements.
  • Biological indicators: Issue, receive, and test biological indicators to verify the effectiveness of our disinfection procedures.
  • Environmental monitoring: Read and report environmental monitoring results, including temperature, humidity, and microbial load.
  • Aseptic qualification: Participate in aseptic qualification activities to ensure the integrity of our production processes.
  • Media fills: Reconcile and inspect media fill units, and participate in media fill activities to ensure the sterility of our products.
  • Microorganism identification: Identify microorganisms isolated during testing activities.
  • Documentation: Complete all laboratory documentation in a timely and accurate manner.
  • Compliance: Ensure compliance with Standard Operating Procedures (SOPs) and Registered Specifications (RS).
  • Authoring and reviewing: Assist in authoring and reviewing documentation, including SOPs, RS, and other technical documents.
  • Paperwork reconciliation: Review paperwork and reconcile analysis performed in the laboratory.
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Requirements:

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  • Education: A minimum of a Level 8 degree in Microbiology or a related discipline.
  • Experience: Strong experience in a pharmaceutical/healthcare laboratory or related technical function.
  • Cleanroom experience: Relevant experience working in a cleanroom environment using aseptic techniques.
  • Isolator experience: Experience working with isolators is advantageous.
  • HPLC and UV Spectrophotometry: Experience in HPLC and UV Spectrophotometry is desirable but not essential.
  • LIMS and LES: Experience using LIMS, LES, and Veeva Vault is desirable but not essential.
  • Communication skills: Excellent written and verbal communication skills.
  • Teamwork: The ability to work in a team-based collaborative environment is essential.
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