Technical Data Reviewer

Company: Cambrex
Location: Agawam
Posted on: January 22, 2023

Job Description:

The Technical Reviewer will work independently within a team to provide a technical data review for laboratory testing data in compliance with GMP standards and FDA / ISO regulations. - This position specializes in various aspects of technical data and documentation evaluation and review, laboratory investigations, and a variety of routine and non-routine quality assurance tasks.

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• As Technical Reviewer, you will be primarily responsible for performing an independent technical review of all test results and data for completeness, accuracy and compliance.
  
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  • Scope: All Microbiological and Environmental Monitoring GxP testing performed in the laboratories at the Agawam, MA facility.
    
  • Method: Ensure all testing was performed per approved SOPs/methods/protocols by critically analyzing the reported data and results for accurate interpretation and conclusion. Ensure all issues/documentation is complete prior to approval.
    
  • Timeline: Provides accurate and timely delivery of data review and report any adverse findings to the appropriate departments to support overall project due dates.
    
    
  • As a Technical Reviewer, may assist in laboratory Investigations.
    
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    • Scope: Out of specification (OOS) and aberrant result laboratory investigations.
      
    • Method: Work with analyst and laboratory management to ensure investigations are completed per approved testing plans. -
      
    • Timeline: - Support timely closure of the laboratory investigation as required by procedure by ensuring testing is reviewed promptly. Escalate issues which may impact timeline to laboratory and quality management.
      
      
      
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      • Requires Bachelor's Degree in Biology, Microbiology, or related science field.
        
      • 6+ years of laboratory testing experience, preferably in the pharmaceutical or biotechnology industries.
        
      • Experience working in GMP testing environment.
        
      • Knowledge and experience with a wide variety of Microbiological techniques including but not limited to Sterility testing, Bioburden testing, Microbial Limits, Endotoxin, and Microbial ID. -
        
        SUCCESS FACTORS:
        
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        • Experience working with LIMS preferred.
          
        • Demonstrated ability to work collaboratively in a team environment.
          
        • Demonstrated ability to think critically and to focus on details of execution.
          
        • Demonstrates ability to work effectively on problems of a diverse scope and with analysis/evaluation of data.
          
        • Expertise with respect to demonstrating theoretical understanding and providing effective evaluation of laboratory practices and methods including compendial methods.
          
        • Experience in authoring, revising, reviewing technical documents such as methods, reports, and protocols.
          
        • Experience in participating and supporting regulatory inspections through explanations of methodologies, investigations, and/or laboratory systems is preferred.
          
          Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
          
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Keywords: Cambrex, Springfield , Technical Data Reviewer, IT / Software / Systems , Agawam, Massachusetts