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QC Incoming Group Leader

Company: Renaissance Pharmaceuticals
Location: Lakewood
Posted on: June 4, 2019

Job Description:

QC Incoming Group Leader OverviewThe purpose of this position is to lead a group of scientific personnel in the execution and timely completion of Raw Materials, Bulk, Finished Product, Stability and Water testing and releases in the Quality Control department.QC Incoming Group Leader Responsibilities

  • Review analytical reports, laboratory notebooks, chromatography data ensuring compliance to test methods and specifications.
  • Review and evaluate method transfer protocols, client/vendor methods for the method transfer activities.
  • Coordinate testing for method transfer activities and process/packaging validations.
  • Coordinate with contract laboratories on scheduling and testing of samples.
  • Ensures analyst's training logs comply with current SOP requirements as well as provide training of lab personnel in methodologies where appropriate.
  • Comply with all Renaissance policies as outline in organizational/departmental guidelines, as well as comply with all applicable SOP's and federal, state and local regulations.
  • Responsible for writing and revising SOP's, investigations, deviations etc.
  • To ensure that the QIS standards are up to date as per current USP, EP compendia.
  • Responsible for releasing the raw materials in timely manner.
  • Ensure good laboratory housekeeping practices and adherence to all Renaissance safety policies and procedures.
  • Required to attend meetings and update team for any immediate requirement related to product/API/Cleaning validation etc.
  • Coordinate with other teams for project work.
  • Shift is 10-6:630 pm QC Incoming Group LeaderQualificationsBachelor's degree required. Master's degree preferred.A minimum of 3 years of relevant experience in the pharmaceutical industry

Keywords: Renaissance Pharmaceuticals, Lakewood , QC Incoming Group Leader, Other , Lakewood, New Jersey

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