QC Analyst

Orion Group Life Sciences are currently recruiting a QC Analyst on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11‑Month contract with potential to extend. Site‑Based Shift Role.

Week 1: Mon 7:00‑17:00; Tue 7:00‑17:00; Wed Off; Thu Off; Fri 7:00‑17:00; Sat 7:00‑19:00 or 9:00‑21:00 (alternate as agreed between shift mates); Sun 7:00‑19:00 or 9:00‑21:00 (alternate as agreed between shift mates). Week 2: Mon Off; Tue Off; Wed 7:00‑19:00; Thu 7:00‑19:00; Fri Off; Sat Off; Sun Off.

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• Comply with and execute CGMP/GDP in the performance of day‑to‑day business activities.
  
• Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and data in day‑to‑day business activities.
  
• Attend and successfully complete applicable CGMP training.
  
• Escalate any potential violation of CGMP and/or other concerns which may affect the safety, efficacy, quality, or purity of MMD human health products.
  
• Work collaboratively to ensure a safe and compliant culture in Carlow.
  
• Participate in driving a high‑performing & inclusive culture, stimulating personal growth & development.
  
• May be required to perform other duties as assigned. Ensure that adequate processes and procedures are in place and followed for all Quality activities.
  
• Where required, work shift patterns in line with manufacturing operations to ensure Quality operations (including testing, delivery and/or oversight) as required per business needs & if needed.
  
• Provide support to the relevant support functions to ensure manufacturing and release of vaccine and biologic products activities, in compliance with applicable procedures, our Company’s Global Policies and Guidelines, regulatory requirements and current Good Manufacturing Practices (cGMP).
  
• Develop and maintain effective cross‑functional relationships with other departments and support functions to ensure that the process for the manufacturing, testing and release of vaccine and biologic products is in compliance with cGMP and the associated regulatory requirements.
  
• Identify and support compliance initiatives to improve compliance status and overall operational efficiency for batch release at the site.
  
• Support business critical projects related to the Quality Department.
  
• Perform laboratory testing and/or materials inspections to determine specification conformance.
  
• Perform all required analytical, microbiological and control testing to support the site. xcfaprz
  
• Maintain an adequate, qualified and compliant laboratory environment to conduct testing while adhering to appropriate PPE and safety requirements.
  

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• Bachelor’s Degree or higher preferred; ideally in a related Science discipline