BrightOwl Loader Loading

Specialist, Quality Systems Document Control El Segundo United States,  

Job Score (company)

Posted on : 11 June 2017

Project 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. 
  • We are seeking a highly motivated individual to join us as a Quality Systems Document Control Specialist.  
  • Implement quality systems associated with Document Management with a focus on batch record and label issuance. 
  • Work closely with SMEs to execute workflows and business processes that align with best practices that ensure right first time. 


Responsibilities (include but are not limited to):
  • Maintain a document management system compliant with regulatory, quality, and company requirements. 
  • Responsible for the management of all documentation and records issuance and archival processes to support clinical and commercial manufacturing. 
  • Provides guidance and advice on approved procedures, standardization and requirements associated with the document management system. 
  • Responsible for maintaining the document change control system. 
  • Executes the document change process so that only approved and validated changes are incorporated into effective product and process documentation. 
  • Ensures accuracy by reviewing documents for completeness, proper authorization and impact to other quality systems. 
  • Collaborates with cross-functional departments to ensure timely implementation of document change requests. 
  • Support audits (internal, external) in order to verify that regulatory and quality requirements have been met. 
  • Perform other duties as required. 

  • Bachelor s Degree. 
  • Minimum 5 years of experience in a quality document management, quality engineering, validation, and quality assurance or quality systems. 
  • Strong knowledge of GMP, SOPs and quality system processes.   
  • Excellent organizational skills and ability to review processes or procedures. 
  • Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic document management systems (Document Locator, documentum, Veeva or equivalent). 
  • Strong written and verbal communication skills. 
  • Ability to communicate and work independently with scientific/technical personnel. 
  • Experience in pharmaceutical or bio-pharmaceutical field. 
  • Education or training in cell culture and gene therapy manufacturing environment a plus. 
  • Quality systems demonstrated working knowledge in areas such as document management, document change control audits, batch record and label issuance. 
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).  
  • The standard work week for this position is Tuesday  Saturday or Sunday -Thursday.  


El Segundo CA

Find a Job Find Candidates

Similar Jobs

More jobs from Kite Pharma

Other jobs in United States

Other jobs in El Segundo

Other similar job in El Segundo

Other Jobs

Most Recent Searches

Most Famous Searches

You might also like