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.