QC Specialist

R&D Partners View all jobs

  • Shannon, Co Clare
  • Permanent
  • Full-time
  • 6 days ago
Safeguard the quality behind life‑changing gene therapies through GMP‑driven QC excellence.R&D Partners is seeking a QC Specialist to support GMP-compliant activities within Quality Control (QC) for the manufacture and release of plasmids and gene therapy products. This role involves contributing to a GMP facility for gene therapy production, with responsibilities spanning equipment qualification, method transfer, routine in-process and release testing, and other QC-supporting activities.Please note that to be considered for this role you must have the right to work in this location.Responsibilities:
  • Support technical transfer of drug substance dilution to QC.
  • Conduct bridging studies for QC dilutions to compare dilution regimes.
  • Execute dilution studies, including equipment installation and qualification.
  • Plan, track, monitor, and execute QC stability studies in accordance with international standards and regulations.
  • Address issues, CAPAs, change controls, action items, and risk assessments within QC.
  • Escalate and resolve QC issues with site leadership.
  • Lead major investigations impacting QC analysis.
  • Author and review scientific and technical documentation.
  • Stay updated on developments in methods and regulations for ATMP analytics.
  • Promote effective communication within the team, across departments, and with external collaborators.
  • Ensure data integrity throughout the data lifecycle.
  • Maintain compliance with GMP, GDP, and GxP guidelines.
  • Support new product introductions and strategic QC-related activities.
Key Skills and Requirements:
  • Analytical Skills: Ability to synthesize complex information and use data-driven insights.
  • Problem Solving: Timely resolution of issues with alternative solutions.
  • Leadership: Inspire and motivate others while accepting feedback.
  • Cost Consciousness: Work within budgets and implement cost-saving measures.
  • Planning & Organization: Prioritize tasks and manage time efficiently.
  • Professionalism: Treat others with respect and maintain composure under pressure.
  • Quality Management: Promote quality improvements and ensure accuracy.
  • Communication: Strong oral and written communication skills, including technical writing.
Qualifications:
  • Degree in Human Health or Sciences, or equivalent relevant work experience.
  • Minimum 8 years of experience in the pharmaceutical or biotech industry.
  • Demonstrated knowledge of GMP environments and quality control.
  • Experience with audits and client-facing interactions.
  • Proficiency in EU/FDA regulations, ICH guidelines, GMP/GLP/GCP, Lean Manufacturing, and Six Sigma.
  • Strong collaboration, communication, and conflict resolution skills.
For more information, please contact Timi Asseez.If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data -

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