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Specialist, Quality Assurance - Operations - United States  

Company managed [?] Still accepting applications

Posted on : 11 June 2017

Project Description

Description:
  • Our company  is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
  •  The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. 



Responsibilities (include but are not limited to):
  • Work with the Manufacturing department as a production area Quality Assurance representative 
  • Coordinate and facilitate Quality Assurance related production and production related activities  
    • Ensure timely issuance of production records, procedures and labels 
    • Ensure timely assessment and closure of discrepancies, Deviations and Change Controls 
    • Review batch-related documentation, and ensure resolution of issues to release product 
    • Communicate lot disposition pending issues to Management 
    • Ensure approval and timely delivery of Final Product    
  • Ensure that products are manufactured in compliance with regulatory and GMP guidelines  
    • Review and approve Manufacturing and Validation documents for Regulatory and our company  compliance 
    • Review and approve Manufacturing Production Records 
    • Compile and verify all batch related documents into a Final Product lot disposition package   
  • Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues 
  • Review and disposition disposable raw materials and components for GMP use 
  • Review equipment and facility technical and investigation reports 
  • Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies 
  • Gather metric information for use in continuous improvement of areas of responsibility.  Report to management as needed. 
  • Perform other duties as required 



Requirements:
  • Bachelor’s degree in Biological Science or related field 
  • Minimum of 5 years Quality and/or Manufacturing experience in a pharmaceutical, biotech, or biologics operation. 
  • Working knowledge of Quality Systems and ability to apply GMPs in conformance to U.S. and EU standards 
  • Ability to effectively negotiate and build collaboration amongst individuals 
  • Strong interpersonal, verbal and written communication skills 
  • Experience with manufacturing investigations, Deviations, and CAPA 
  • Experience with Change Control practices and strategies 
  • General knowledge of aseptic manufacturing processes 
  • Knowledge of equipment, facility, and utility IQ/OQ/PQ 
  • Proficient in MS Word, Excel, Power Point and other applications 
  • Ability to communicate and work independently with scientific/technical personnel 
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities