QC Chemist
Day shift
Cincinnati, OH Area

Seeking a QC Chemist in a pharmaceutical GMP (Good Manufacturing Practice) environment.  This role will perform analytical testing for various samples including but not limited to in-process, finished product, stability, raw material, cleaning verification/validation, and development and validation samples.  Performs data review. Participates in laboratory investigations, related to QC processes or data. Supports validation, method development and transfer activities, trains QC employees, supports laboratory equipment qualifications, investigations and change control management.
Job Responsibilities:

• Analytical Testing:
  

  • Performing complex analytical tests on a wide variety of samples (in-process, finished product, stability, raw materials, etc.).
    

  • Utilizing various analytical techniques, with a strong emphasis on HPLC/GC.
    

  
  

• Data Review and GMP Compliance:
  

  • Conducting thorough GMP reviews of laboratory documentation, including electronic data.
    

  • Ensuring compliance with SOPs, test methods, regulations, and protocols.
    

  • Communicating findings and following up on corrections.
    

  
  

• Quality Investigations and Troubleshooting:
  

  • Participating in laboratory investigations, including OOS (Out of Specification) and atypical events.
    

  • Performing root cause analysis and ensuring accurate documentation.
    

  • Troubleshooting methods and processes.
    

  
  

• Method Development and Validation:
  

  • Supporting validation, method development, and transfer activities.
    

  • Actively supporting the implementation of compendial changes (USP/NF, etc.).
    

  
  

• Equipment Management:
  

  • Maintaining and troubleshooting testing equipment.
    

  • Supporting laboratory equipment qualifications, investigations, and change control.
    

  
  

• Training and Mentorship:
  

  • Training QC employees in analytical techniques, methods, instrumentation, GMP, and SHE (Safety, Health, and Environment).
    

  
  

• Continuous Improvement:
  

  • Evaluating data trends and identifying areas for continuous improvement.
    

  • Leading continuous improvements in laboratory processes.
    

Key Skills and Qualifications:

• Analytical Expertise:

  • Analytical experience in a pharmaceutical GMP facility is a plus.
    

  • Proficiency with HPLC/GC and chromatography software (e.g., Empower).
    

  
  

• GMP Knowledge:
  

  • Understanding of GMP regulations and quality control principles.
    

Job Details:

• Temp-to-Hire
  

• Competitive salary; Full Benefits Package
  

• Monday-Thursday; Day Shift

9749521