QC Analyst

Exciting opportunity to joinaleading biomaterial and polymer technology start-up companyin theirbrand newfacility inNewcastle West, Limerick.TheQC Analystis 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 astart-up environmentand wants to contribute to the success of a new facility.Experience in a regulated environment 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 Bachelors 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 contactBarry O'Brien. Skills : Quality Assurance Quality Control Quality Pharmaceuticals Medical Device