Analytical Chemist/Research Scientist

Location: Groton, Connecticut
Posted On: 9/7/2017
Job Code: 8537
Job Description
Job Description: The analyst will analyze samples in support of the elemental impurities initiative for commercial products for Global Supply. The scientist will assure compliance with element-specific based limits as stipulated in ICH Q3D “Guideline for Elemental Impurities” to meet FDA, EMA and rest of world requirements. The candidate will work in the Inductively Coupled Plasma – Mass Spectrometry (ICP-MS) laboratory supporting testing of drug products received from the PGS network. Position will include but not limited to the preparation of standards and samples in an array of complex matrices. Maintenance of instrumentation (ICP/MS and microwave digester), ordering of reagents, standards and consumables. This position will require tracking of samples within the laboratory, analysis of samples following SOPs, review of data generated and reporting of final results. Specific responsibilities include: • Preparation of samples suitable for analysis of trace level elemental impurities • Maintaining inventory of reagents, standards and consumables • Maintaining facilities to ensure safe, efficient operations and accurate results • Aid in the reporting of risk assessments as a deliverable to manufacturing sites • Issuance of periodic progress reports to Hub management Skills: Category Name Required Experience No items to display. Additional Skills: • Experience with ICP-OES and or ICP-MS operations is a plus • Knowledge of quality and compliance regulations • Excellent written and verbal skills • Experience in analyzing samples in a high thru-put environment Degree in a scientific or engineering discipline with 2 years of experience related to analysis of elemental impurities
Category:Non-IT  code:new
Job Requirements
Engineering, Compliance, Management

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Ajaykrishnan Ks