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QC Scientist / Associate Scientist

Job Responsibilities

  • Perform functional assays for in-process and finished formulations in support of manufacturing and product release, including HPLC, Peptide Mapping, ELISA assays, SPR methodology or microbiological analysis.
  • Provide scientific and technical expertise to support operations in Quality Control Department, including analytical method validations and technology transfer to other GMP sites.
  • Improvise standard operating procedures and guidance for QC operations in compliance with GMP regulations.
  • Document writing for transfer, validations and investigations.
  • Independently drive projects to on-time completion.

Job Qualifications (Education, Certifications, Experience)

  • Bachelor’s degree in a scientific discipline with 8+ years experience in quality control, or Master’s degree with 5+ years experience. 
  • Strong computer system and database skills with 3+ years experience in LIMS operation
  • Thorough knowledge of GMP regulations and documentation. 
  • Ability to train others in the application of GMP. 
  • Good overall understanding of the statistics required in relevant QC data analysis.
  • Excellent verbal and written communication skills. 
  • Thorough understanding of quality control systems. 
  • Ability to work effectively across departments regarding quality-control matters. 
  • Strong technical writing skills. Demonstrated technical proficiency, scientific creativity, collaboration with others and independent thought. 
  • Demonstrated capability and ability to effectively plan for short term and long range needs. Ability to investigate and solve problems.