Exciting opportunity to join a leading biomaterial and polymer technology start-up company 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 is preferred.
Overview of Main Responsibilities:
* 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.
* 2+ years of related experience minimum.
* Knowledge of analytical instrumentation (GC, HPLC, UV-VIS, etc.)
* Experience working in an ISO or FDA regulated environment preferred.
* 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 Barry O'Brien.
Skills: Quality Assurance, Quality Control, Quality, Pharmaceuticals, Medical Device
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