JVT Advisors

Sr. Specialist, External QC

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Location: Norwood, Massachusetts 02139
Employment Type: Contract

Job Description

Contract Length: 9+ months

 

Job Summary: This individual will support External QC testing for outsourced commercial manufacturing testing and will support QC administrative functions with contract testing laboratories and contract manufacturing organizations.

 

Responsibilities:

  • Assist in testing program support at contract manufacturing organizations and contract laboratories for raw materials, drug substance and drug products
  • Participate in cross-functional project teams to lead Quality Control related activities
  • Provide QC support for method transfers and validations projects as required
  • Troubleshoot and provide further technical support for method, material, and instrument related issues
  • Review/approve procedures, protocols and reports
  • Support technical assessments of quality events such as deviations, investigations, and change controls

Requirements:

  • Bachelor’s degree in a relevant scientific discipline
  • Minimum 5+ years in a cGMP laboratory and/or GMP manufacturing with focus in analytical chemistry or Biochemistry
  • Knowledge of compendia and analytical test methods, technical writing, and knowledge of the QC requirements
  • Experience/Knowledge of Veeva and Lab Vantage LIMS
  • Knowledge of method transfers and qualifications
  • Excellent quality control judgment and ability to assess, communicate and resolve complex issues efficiently and effectively

Christian Griffith

Recruiter

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