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Analytical Chemist I
Ref No.: 17-03436
Location: Groton, Connecticut
Start Date / End Date: 11/20/2017 to 05/19/2018
The analyst will analyze samples in support of the elemental impurities initiative for commercial products for Pharmaceutical 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