Quality Assurance Specialist: Microbial Analysis Expert

2 weeks ago

Dublin, Dublin City, Ireland beBeeMicrobiologist Full time €60,000 - €85,000

About PSC Biotech:

  • A leading biotech consultancy firm founded in 1996, headquartered in California, USA, with global operations in Ireland, India, Singapore, Australia, and the US.
  • Serves 350 clients in more than 23 countries worldwide, providing cloud-based software solutions for quality management and regulatory inspections.

PSC Biotech disrupts the conventional consultancy model by offering a unique employee value proposition (EVP), including opportunities to work with talented professionals in the pharma/biotech industry.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech. We provide empowering career development through learning & development, in-house training, mentorship, and guidance to facilitate career progression.

The QC Microbiology Analyst Role

This role is crucial in ensuring compliant design, construction, qualification, and operation of the new biotech drug substance facility in Swords.

  1. Qualify the microbiology QC lab and transfer microbiological analytical methods, including rapid microbiological methods.
  2. Design the lab testing flow for efficiency and lean principles.
  3. Develop expertise in microbiology and chemistry labs.
  4. Support other analysts, train, and guide within the lab.

Responsibilities include analytical transfer and qualification of methods, as well as supporting other analysts, training, and guidance within the lab.

The analytical scope includes microbiology, mycoplasma (DNA) analytics, analytical chemistry, bioassay, raw materials, stability, and in-process testing.

Advanced methods like rapid ID techniques and paperless labs will be used.

Key responsibilities include:

  • Performing routine microbiological techniques, including environmental monitoring, WFI testing, growth promotion testing, in-process and final product testing.
  • Completing documentation timely and being familiar with LIMS.
  • Training in rapid microbiology techniques.
  • Following current analytical practices per pharmacopoeias, regulations, and standards.

Requirements for success include motivation to be part of a high-performing team, desire to learn, improve, and develop, and support activities for lab readiness, equipment qualification, and method transfers.

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