Quality Control Analyst II, Lab Support [Contract to Hire]

Company: Iovance Biotherapeutics
Location: Philadelphia
Posted on: March 19, 2023

Job Description:

Overview
Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. Iovance is seeking a Quality Control (QC) Laboratory Support Analyst II who will assist the Laboratory Manager with the day-to-day upkeep of the QC laboratories including but not limited to maintaining a trending database, maintaining positive control inventories for various QC assays, and assist with out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA).
S/he will have experience working in a GMP-regulated laboratory with pipetting knowledge.The position will report to the Lab Support Manager, Quality Control.
SpecificResponsibilities

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• Works with QC Lab Support Manager with responses to audits, deviations, out of specification/lab investigations, customer complaints, and corrective/preventative actions (CAPA)
  
• Maintains a Critical Reagent Inventory for the QC Qualification and Testing Program
  
• Maintains a Positive Control Inventory for the QC Qualification and Testing Program
  
• Maintains a Trending Program for key attributes of the various Iovance programs
  
• Perform laboratory testing to investigate and/or trouble-shoot atypical/out of specification results
  
• Upload and create records of reviewed QC assay records to the Document Management System
  
• Author and review CoAs and CoTs for product release
  
• Assists in the technical review of testing and laboratory records for accuracy and compliance with cGMP and the company's standard operating procedures
  
• Holiday and weekend work may be occasionally required
  
• Other responsibilities as assigned
  
  Education and Qualifications
  
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  • Bachelor's degree in a relevant discipline (biological sciences or equivalent)
    
  • At least 3 years of experience in the biopharmaceutical industry within a cGMP Quality Control role
    
  • Experience with cell and/or gene therapy products is a plus
    
  • Experience with cell-based assays, ELISA and/or flow cytometry is a plus
    
  • A basic knowledge of biological drug development with respect to Quality Control
    
  • Extremely detail-oriented with strong analytical, written, and verbal communication skills
    
  • In-depth knowledge of GDPs
    
  • Demonstrate sense of urgency; ability to recognize time sensitivity
    
  • Flexible and adaptable style with an eagerness to take on challenges
    
    Physical Requirements
    
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    • Sit for an extended amount of time in front of the computer or biological safety cabinet
      
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Keywords: Iovance Biotherapeutics, Philadelphia , Quality Control Analyst II, Lab Support [Contract to Hire], Healthcare , Philadelphia, Pennsylvania