QC Analyst

  • Dublin South
  • Temporary 12 months
  • JO-1906-64597_1561622953


The position will involve working with the QC Chemical and Analytical Sciences (CAS) team to ensure all testing is performed as per regulatory requirements, cGMP and site procedures.


  • Testing stability and finished product samples, Eg Ph, Appearance, Colour, Clarity, Sub Visible Particle testing, Osmolality, Protein Concentration, Polysorbate, Moisture and Device testing (Sub Visible, Protein Concentration and Polysorbate - preferred)
  • Training of QC Chemistry Laboratory colleagues
  • Document review/updates
  • Peer-Review work
  • Review and authorisation of Lab Data
  • Possibility of testing of raw materials (not key focus, small part - however applicants will need some experience, Pharmaceutical Compendia)
  • Support Analytical Technical Transfer activity testing reports and documentation.
  • Monitoring of site water and Nitrogen systems
  • Equipment Maintenance and Trouble Shooting
  • Method Validation/Verification
  • Laboratory Investigation support
  • Laboratory Housekeeping and maintaining GLP standards
  • Assisting in regulatory audits


  • Bachelor's degree in a science discipline.
  • 3+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
  • Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products
  • Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning
  • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

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