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QC Analyst II/ Sr QC Analyst  - United States  

Company managed [?] Still accepting applications

Posted on : 22 December 2017

Project Description

The QC Analyst will report directly to the QC Manager and will be primarily responsible for performing in-process testing of Repligen Bioprocessing ligands, and release of OPUS pre-packed chromatography columns.  The analytical activities supporting this position include FTIR analysis of pre-packed OPUS columns. The successful candidate will support activities for facilities including collection of Environmental Monitoring data in the clean rooms as well as RODI collection and analysis.  The candidate will actively follow Repligen ISO 9001 Quality Management System in support of the Bioprocessing manufacturing processes and final product testing, including additional laboratory compliance as assigned by the QC Manager. 

Responsibilities: 

  • Performs final testing of finished OPUS® pre-packed chromatography columns and documents results for product release, and assists with any additional OPUS related QC requirements 
  • Performs in-process concentration analysis by UV 
  • Performs ELISA testing 
  • Performs sample preparation for FTIR analysis in support of the OPUS manufacturing 
  • Carries out monitoring of controlled environments and records data for trend analysis
  • May assist with OOS investigations, failure investigations and change controls associated with QC testing 
  • Perform RODI water testing

Qualifications: 

  • Requires college level education in Biology or related field and 2 – 4 years’ experience in Quality Control laboratory or equivalent 
  • Ability to work independently once training has been completed 
  • High attention to detail applied to all aspects of daily activities 
  • Ability to work efficiently in an ISO-9001 quality system with appropriate attention to detail in the performance of controlled procedures 
  • Good understanding of the fundamentals of column chromatography 
  • Experience in the following QC assays:   Microbiological assays (environmental monitoring, water testing, bioburden, endotoxin), HPLC, Gel electrophoresis and FTIR