CQV Specialist

Company: Katalyst Healthcares & Life Sciences
Location: Raritan
Posted on: March 20, 2023

Job Description:

Job Description :

• 
  
• Responsible for the day to day activities including execution, protocol management,
  
• vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems, and processes in support of personalized cell therapy production according to cGMP requirements.
  
• Work in a collaborative team setting with Quality, Manufacturing Operations, Facilities & Engineering Quality Control, Operations Technical Support, Supply Chain and Planning.
  
  Roles & Responsibilities :
  
  
  • 
    
  • Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant
    
  • Manages multiple and complex CQV projects, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks.
    
  • Supports and/or owns technical and quality investigations, CAPAs and corrections.
    
  • Develops and performs any required remediation efforts and associated CAPA plans.
    
  • Authors, owns and executes master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity.
    
  • Executes, owns, assesses, and participates in the creation, revision and review of change controls, SOPs, and other documentation.
    
  • Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews
    
    Education & Experience :
    
    
    • 
      
    • Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
      
    • Strong interpersonal and written/oral communication skills.
      
    • Ability to quickly process complex information and often make critical decisions with limited information.
      
    • Proficient in applying process excellence tools and methodologies.
      
    • Ability to independently be responsible for a portfolio of ongoing projects.
      
    • Ability to pay attention to details and follow the procedures.
      
    • The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
      
    • Good written and verbal communication skills are required.
      
    • Ability to summarize and present results, and experience with team-based collaborations is a requirement.
      
    • Ability to work with others in a team environment.
      
    • Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
      
    • Ability to identify/remediate gaps in processes or systems.
      
    • Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
      
    • Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, CQV protocols.
      
    • Experience with TrackWise, CMMS and Maximo
      
    • Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
      
    • Experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance.
      
    • Demonstrated ability to work independently, drive effective communication, coordination, and collaboration across relevant cross functional groups to establish a strong, compliant CQV program to enable robust production, testing and release of product to patients.
      
      

Keywords: Katalyst Healthcares & Life Sciences, Trenton , CQV Specialist, Other , Raritan, New Jersey