QC Analytical Scientist

Scientist – Analytical / Quality Control

About the Role

The Scientist supports analytical testing for new and commercial pharmaceutical products using a variety of analytical technologies and laboratory techniques. This role is responsible for testing raw materials, intermediates, finished products, and stability samples to support product development, manufacturing, and quality control activities. The Scientist analyzes and interprets data, documents results, and communicates findings through technical reports and presentations while ensuring compliance with cGMP and regulatory standards.

Key Responsibilities

Analytical Testing & Laboratory Operations

• Perform analytical testing on raw materials, in-process samples, finished products, and stability samples
  

• Conduct laboratory testing using chromatographic methods, dissolution testing, and standard wet chemistry techniques
  

• Operate analytical instrumentation including LC/HPLC, GC, and dissolution systems
  

• Execute laboratory activities accurately and efficiently with minimal errors in testing and documentation
  

• Independently complete assigned projects and testing activities within established timelines and deliverables
  

• Use laboratory systems such as CDMS, LIMS, and ELN for data management and documentation

Data Review & Reporting

• Interpret, evaluate, and properly document analytical results
  

• Review data for accuracy, completeness, and integrity
  

• Prepare technical reports, presentations, protocols, SOPs, specifications, and analytical methods
  

• Support and document laboratory investigations, deviations, and corrective actions

Collaboration & Compliance

• Collaborate with cross-functional teams to ensure project and quality requirements are achieved
  

• Support quality systems, laboratory processes, and change management activities
  

• Maintain compliance with cGMP, safety, environmental, and regulatory requirements
  

• Adhere to company standards for data integrity and documentation practices
  

• Perform additional technical and administrative duties as needed to support business objectives

Qualifications

Education & Experience

• Associate’s degree in Chemistry or Analytical Chemistry with 5+ years of pharmaceutical analytical laboratory experience
  OR
  

• Bachelor’s degree in Chemistry or Analytical Chemistry with 3+ years of pharmaceutical analytical laboratory experience

Technical Skills

• Experience in analytical quality control and pharmaceutical product development
  

• Hands-on experience with analytical instrumentation including:
  

  • LC/HPLC
    

  • GC
    

  • Dissolution systems
    

  
  

• Familiarity with CDMS, LIMS, and other laboratory data management systems
  

• Proficiency with Microsoft Office applications including Teams, Word, Excel, and PowerPoint
  

• Strong understanding of analytical methods, scientific principles, and laboratory procedures

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