QC Analyst

Job Summary:

We are currently seeking a QC Analyst to join a well-known biopharmaceutical organisation based in Waterford on an initial 12-month contract. This is an excellent opportunity to work within a state-of-the-art laboratory environment, supporting quality control testing activities that ensure the highest standards of product quality, safety, and regulatory compliance. The successful candidate will play a key role in analytical testing, data review, investigation support, and continuous improvement initiatives within a GMP-regulated setting.

Responsibilities:

• Perform analytical testing in accordance with approved methods, procedures, and GMP requirements.


• Support release testing for raw materials, intermediates, and finished products.


• Review, maintain, and update analytical methods, specifications, and laboratory SOPs.


• Prepare and review Certificates of Analysis (CoAs) and trend analytical data.


• Investigate Out of Specification (OOS) results and support root cause investigations.


• Ensure laboratory records, documentation, and test results are accurate and compliant.


• Collaborate with Quality Assurance, Manufacturing, Engineering, and Planning teams.


• Provide training and support to laboratory colleagues on testing methods and procedures.


• Support equipment qualification and validation activities (IQ/OQ/PQ) where required.


• Maintain compliance with cGMP, cGLP, and all relevant quality and regulatory standards.


• Identify and recommend process improvements to enhance laboratory efficiency and compliance.

Requirements:

• Degree qualification in Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or a related scientific discipline.


• A minimum of 2 years experience working in a GMP-regulated pharmaceutical, biotechnology, or life sciences laboratory.


• Strong analytical and problem-solving skills with excellent attention to detail.


• Ability to work independently while also contributing effectively within a cross-functional team.


• Excellent organisational, communication, and time-management skills.


• Experience with some or all of the following would be advantageous:
  
  
  
  • ELISA
  
  
  • UV Spectroscopy
  
  
  • SDS-PAGE
  
  
  • Biacore (Receptor Binding)
  
  
  • Osmolality Testing
  
  
  • Oxygen Headspace Testing
  
  
  • Karl Fischer Moisture Analysis
  
  
  • HIAC Particulate Testing
  
  
  • SoftMax Software
  
  
  • Strong micropipetting techniques
  
  


• Solid understanding of GMP requirements and laboratory documentation practices.