QC Microbiology Analyst

2 weeks ago

Dublin, Dublin City, Ireland PSC Biotech Ltd Full time

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PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US. We serve 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services.

Employee Value Proposition

Employees are the "heartbeat" of PSC Biotech. We offer empowering career development through in-house training and mentorship, fostering high-performing teams that exceed client expectations in quality, budget, and timelines.

Overview

  • The QC Microbiology Analyst role is crucial for ensuring the compliant design, construction, qualification, and operation of the new biotech drug substance facility in Swords. Responsibilities include qualifying the Microbiology QC lab, transferring microbiological analytical methods, and optimizing lab testing flow.
  • The candidate will develop expertise in analytical microbiology techniques and pharmacopeial methods, working with advanced technologies and automation in a collaborative environment.
  • Support and train other analysts, participate in analytical transfer and qualification, and work across microbiology, mycoplasma, chemistry, bioassay, and stability testing areas.

Shift Pattern

  • Initially days, then shift 7-7, 4 days on/4 days off, 12-hour days.
Requirements
  • Motivation to be part of a high-performing team and a desire for continuous learning.
  • Support lab readiness, equipment qualification, and method transfers.
  • Perform routine microbiological analyses in GMP environment.
  • Maintain documentation, update SOPs, and support testing schedules.
  • Manage samples, reagent prep, equipment maintenance, and ensure GLP compliance.
  • Participate in audits, risk assessments, and corrective actions.
  • Train new analysts, manage supplies, and uphold cGMP standards.
  • Drive continuous improvement using Six Sigma tools.

Qualifications

  • 1-2 years relevant experience, preferably in analytical microbiology within GMP settings.
  • Knowledge of cGMP and microbiology techniques.
  • Understanding of business processes and effective communication skills.
  • Third-level science qualification (Microbiology preferred).
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