JVT Advisors

Specialist, Quality Control

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Location: Norwood, Massachusetts
Employment Type: Contract

Job Description

Contract Length:  6+ months

Job Summary:  This person will assist lab management in OOS/OOT/OOE/LE investigation, troubleshooting methodologies, providing corrective actions and preventive actions (CAPAs), and SME training for the department. This role is assigned to the 3rd shift from Wednesday to Saturday (4 x 10 hrs., 10 pm to 8 am).

  • Perform QC analytical chemistry testing including, but not limited to HPLC, UPLC, GC, UV, CE, Particle Count analysis, and Dynamic Light Scattering, KF, Osmolality, Digestion, etc,
  • Ensure the analytical testing and laboratory documentation meet cGMP and GDP requirements.
  • Perform raw material, in-process (STAT), finished product and stability sample analysis when needed.
  • Support method validation/transfers and special projects as assigned
  • Ensure stability testing completed within the required timeline.
  • Perform troubleshooting methods and equipment
  • Actively support OOS, OOT, OOE, QE and LE investigations and be able to write investigation reports.
  • Bachelor’s degree in a relevant scientific discipline, preferred in Analytical Chemistry, or Chemistry
  • 5 years in a laboratory setting with focus in analytical chemistry
  • Strong mathematical skills, including the ability to analyze scientific and test data, and solid understanding of statistical analysis
  • Have in-depth knowledge of Analytical Chemistry theory (especially chromatographic separations by HPLC) and the operation of analytical laboratory equipment
  • Have in-depth knowledge of analytical chemistry related to the SOPs and testing methods, especially for chromatographic separations using UPLC/HPLC/GC and the operation of general analytical laboratory equipment
  • In-depth knowledge and expertise in method transfers/qualifications/validations
  • Solid knowledge on cGMP, USP/EP/JP compendia testing requirements
  • Solid knowledge of lab safety
  • Highly proficient use of Microsoft Word and Excel, Chromatographic Software

Jared Potter

Principal Recruiter

He's a natural people person.

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