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Specialist, Quality Systems Document Control El Segundo United States,  

Job Score (company)


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. 
  • 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. 
 


Requirements:
  • 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.  
 

Locations

El Segundo CA

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