QC Scientist

Job Title: QC Scientist Pharmaceutical Manufacturing Support
Job Summary:
We are seeking a skilled and experienced QC Scientist to support the manufacturing of pharmaceutical products. The primary responsibilities include routine testing and analysis of finished products (tablets, capsules, sub-gels) and raw materials, utilizing a variety of laboratory instruments and techniques. This position requires hands-on experience with a range of analytical instruments and the ability to perform stability testing, assay testing, and other essential chemical analyses in compliance with internal SOPs and USP monographs. The ideal candidate will have a strong background in pharmaceutical testing and a proven track record working with oral solid dosage forms and raw materials.
Key Responsibilities:

• Routine Testing and Analysis:
  Conduct routine analysis of finished products and raw materials, including weight, chemistry tests for raw materials, and stability sample testing under different ICH conditions.
  
• Testing and Assays:
  Perform a range of tests, including assay, identity (ID), content uniformity, blending uniformity, impurity testing, water content determination, content resolution, disintegration, and hardness testing.
  
• Instrument Proficiency:
  Operate and troubleshoot laboratory instruments such as HPLC, UPLC, GC, Karl Fischer, FTIR, visualization testers, and pH meters. Experience with chromatography software (e.g., Empower 3) is highly preferred.
  
• Methodology Compliance:
  Follow approved testing procedures and methods according to internal SOPs and USP monographs. Report data accurately and promptly.
  
• Data Review and Trending:
  Conduct peer data reviews and analyze data trends to ensure consistent results. Participate in laboratory investigations using TrackWise software.
  
• Collaboration and Support:
  Assist other scientists and laboratory personnel to ensure timely completion of projects. Support routine lab activities such as balance calibration, pH calculations, and other day-to-day tasks.
  
• Stability and Medical Testing:
  Perform stability testing of pharmaceutical products and excipients under ICH conditions, and assist with medical testing as necessary.
  
• Software Utilization:
  Utilize Empower 3 chromatography software for HPLC and UPLC analysis.

Position Requirements:

• Education and Experience:
  • 4-8 years of hands-on experience in a laboratory setting, with a focus on oral solid dosage forms (tablets, capsules, sub-gels) and raw materials.
    
  • Strong working knowledge of pharmaceutical testing, including stability testing and compliance with USP standards.
    
  • Experience with laboratory instrumentation such as HPLC, UPLC, GC, Karl Fischer, FTIR, and pH meters.
    
  • Prior experience with Empower 3 software or similar chromatography software is a significant advantage.
    
• Skills and Knowledge:
  
  • Strong understanding of pharmaceutical testing methods, including assay, identity testing, content uniformity, and impurity analysis.
    
  • Ability to perform digital testing using HPLC and UPLC, and the ability to troubleshoot and calibrate equipment as needed.
    
  • Knowledge of data review processes, trending, and documentation of test results.
    
  • Ability to adhere to SOPs, USP monographs, and GMP regulations.
    
  • Strong communication and teamwork skills to collaborate with other lab personnel and ensure project completion.
    

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