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Quality Control Specialist II

Company: Clene Nanomedicine
Location: North East
Posted on: August 8, 2022

Job Description:

The Quality Control Analyst II (QC II) will assist in the analysis of bioanalytical specimens obtained from animal studies and clinical studies conducted at contract research organizations. In addition, this individual will perform analyses of production samples received from the manufacturing plant or the research and development laboratory. The individual will be required to follow all Standard Operating Procedures (SOPs) and Test Methods (TSMs); Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and internal processes.

---Assist in the analysis of bioanalytical specimens (e.g., blood, urine, tissues)
---Support development of validation protocols/reports
---Create and edit test methods and other quality documents.
---Perform analytical characterization using the following equipment:oCEM Discover SPD microwave digester
oAgilent ICP-MS 7700x/7900
oMalvern Zetasizer ZS90
oThermoFisher UV-Vis
opH/conductivity meter
oShimadzu TOC-Vwp
---Follow cGMP and cGLP standards, TSMs and SOPs
---Execute and lead lab equipment validation and qualification when necessary
---Calibrate analytical instrumentation
---Maintain supply inventory and MSDS sheets, including requesting purchase orders
---Attend as necessary and successfully complete training on analytical instrumentation and proceduresas well as other directed areas of interest
---Reports to lab supervisor any issues that may affect the identity, strength, quality, and purity of theproduct or that may improve the lab performance
---Perform lab equipment verification
---Lead research and development experiments
---Troubleshooting equipment
---Assist in the shipping of samples for outsource testing


Keywords: Clene Nanomedicine, Wilmington , Quality Control Specialist II, Other , North East, Delaware

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