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QC Analyst II

Exciting opportunity to join Ortec Inc. in their brand new facility in Newcastle West, Limerick. The QC Analyst is responsible for daily laboratory testing of raw materials, in-process and finished products. In addition, this position is responsible for providing support for environmental testing, validation, stability, and other various laboratory and production testing. This is a great opportunity for someone who is looking to work in a start-up environment and wants to contribute to the success of a new facility. Experience in a regulated environment and EMPOWER is preferred.

Overview of Main Responsibilities (full job description available on request):

  • Perform chemical testing using analytical instrumentation including HPLC, GC, FTIR, UV-VIS, etc.
  • Assist in sampling of raw materials upon receipt, when needed.
  • Aid in maintaining quick turnaround time of raw material release.
  • Familiar with Quality GMP documentation (hard copy and electronic) of testing results and assurance of laboratory data integrity.
  • Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep proper documentation in compliance with SOPs.
  • Experience with USP interpretation and testing.
  • Support QC audit readiness with understanding of FDA and ISO regulations and requirements.
  • Support on-time performance in the QC lab against the Production and laboratory schedules.
  • Assist with maintenance and troubleshooting of QC lab equipment to minimize downtime.
  • Employ sound and compliant laboratory techniques and logic per industry standards (e.g., FDA, USP/NF, ISO, ANSI) and internal and customer requirements.
  • Troubleshooting laboratory instrumentation.
  • Review batch records to ensure they are compliant with SOPs, WIs, and cGMPs
  • Any additional functions as assigned by the Laboratory Lead.

What the ideal candidate looks like:

  • Minimum of a Bachelor’s degree in Chemistry or related scientific field.
  • 4+ years of related experience.
  • Knowledge of analytical instrumentation (GC, HPLC, UV-VIS, etc.)
  • Experience working in an ISO or FDA regulated environment preferred.
  • Familiarity with Empower.
  • Excellent communication skills, including the ability to speak clearly, listen and gain clarification, respond well to questions, and write clearly and informatively.
  • Ability to deal with problems involving several concrete variables in standardized situations.
  • Proficiency with Microsoft Word, Excel, and Access.

For a confidential discussion and more information on the role, please contact Aisling Lane.

(021) 4320675