JVT Advisors

QC Associate II, Stability

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Location: Norwood, Massachusetts 02139
Employment Type: Contract

Job Description

Contract Length:  6+ Months

Job Summary:  The individual in this role will perform in process, release and stability testing in quality control Chemistry laboratory and may support special projects as assigned.   This position will be the third shift (10 pm - 8 am) from Sunday to Wednesday.

  • Work on in-process, release and stability testing for raw materials, drug substance, intermediates, and drug products in accordance with cGMP, SOP, FDA, ICH and other regulatory requirements.
  • Routinely use analytical equipment including, but not limited to HPLC, UPLC, LC-MS, GC, UV plate reader, particulate matter, particle size analysis with Dynamic Light Scattering, KF, Osmolality, etc.
  • Follow current test methods and/or protocols to perform analytical testing
  • Document the testing procedure and results using Assay Performance Worksheets and/or LIMS as per GDP requirements and submit data packets for review
  • Maintain compliance to data integrity and cGMP in QC lab in line FDA and ICH guidance.
  • BA/BS in Chemistry (preferred) or other relevant scientific discipline
  • Working experience:  at least two years in quality control laboratory in a pharmaceutical company
  • Solid experiences with general laboratory operations (Micropipette and analytical balance use, pH, reagent preparation, centrifuge, etc.)
  • Practical working knowledge of QC instrumentation and related software
  • Hands on experience with HPLC and UV instrumentation and chromatographic software
  • Strong technical writing ability
  • Proficiency with Microsoft Office Programs
  • Familiarity with electronic databases (e.g. LIMS, SAP, LMS, Veeva, Chromeleon, or equivalent software)
  • Strong written and oral communication skills as well as organizational skills

Jared Potter

Principal Recruiter

He's a natural people person.

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