Quality Control Specialist-Large Molecule

Quality Control Specialist-Large Molecule

Exton, PA (Corporate)

Quality Control Specialist-Large Molecule

Exton, PA (Corporate)

Responsibilities

  • Review of Biologics bioanalytical data (notebook documentation, raw data and LIMS data) for accuracy, consistency and completeness to ensure compliance with SOPs and GLP.
  • Review method development/qualification/validation reports and sample analysis reports including text and data for accuracy and consistency.
  • Preparation of bioanalytical test result data tables for clinical testing reports. Review of client data transfer specifications. Prepare and transmit client data transfer tables. Other duties as assigned.

Requirements

  • Bachelor’s degree in chemistry, biochemistry, immunology or other related scientific field
  • Quality control or  quality review / audit experience within a biotech/CRO/pharmaceutical or laboratory environment
  • Proficient in Microsoft Excel .
  • Experience working in a regulated GMP/GLP environment
  • Experience working with Watson LIMS system is a plus
  • Working knowledge in the use ligand binding methods (ELISA, MSD, Gyros)
  • Familiar with PK, ADA and Biomarker data generated via ligand binding assays

 

 

 

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