Quality Control Specialist II
Company: Clene Nanomedicine
Location: North East
Posted on: August 8, 2022
|
|
Job Description:
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.
Requirements:
---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
PI187037816
Keywords: Clene Nanomedicine, Wilmington , Quality Control Specialist II, Other , North East, Delaware
Click
here to apply!
|