Quality Control/Analytical Specialist

  • Contract

Company Description

We are one of the leading technical resource provider for Pharmaceutical & life science industries. We have 100+ employees working for major Pharmaceuticals Giants such as Merck, Novartis, BMS and Takeda. 

Job Description

  • Perform analytical testing of raw materials, in-process samples, finished goods and stability samples in a GMP/GLP laboratory environment. 
  • As needed, serve as primary lead investigator or support investigator for out of specification investigations
  • May act as a backup to Microbiological Specialist to conduct microbiological analysis on raw materials, in-process goods, and/or finished products and make evaluation to determine conformance to specification.
  • Maintain data documentation in accordance with cGMP and company standards.
  • Interface with personnel from other companies/laboratories regarding testing discrepancies and method/instrument problems.
  • Maintain inventory of chemicals, apparatus, and equipment for analytical laboratory and satellite laboratories.
  • Maintain the analytical lab in accordance with GMP/Plant housekeeping procedures.

Qualifications

  • 3+ years’ experience in a GMP-regulated laboratory required
  • Experience with reverse phase HPLC chromatography and Gas Chromatography a plus. Experience with Agilent chromatography systems and Chemstation/OpenLab software is a plus.
  • Experience with AA and UV assays a plus
  • Working knowledge of USP, EU compendia test methods for raw material testing.
  • Experience conducting OOS investigations a plus.
  • Collegiate undergraduate/graduate research experience may be considered in lieu of work experience.

Additional Information

All your information will be kept confidential according to EEO guidelines.

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