Quality Associate/Document Control Specialist

BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Quality Document Control Specialist to work for a leading Orange County pharmaceutical company.
 

Quality Associate/Document Control Specialist

Temp-to-hire – 6 months
Pay Rate: $20/hour


Responsibilities:
  • Collect and maintain documentation for quality control and product dossiers. 
  • Assist with outline and development of organizational SOPs. 
  • Ensure the company documentation control system follows corporate policies, FDA cGMP and other regulations by control of documents, including the review, change, control, distribution, retention and archiving of relevant R&D documentations.  
  • Develops and maintains a comprehensive filing system and computer database for all documents to be retained in the document control center 
  • Manages the operation of the document control center to ensure that all users have the latest revision of appropriate documentation in a timely manner. 
  • Acts to support Change Control Board in organization and tracking of all outlined and required/impacted changes
  • Collect and maintain files of the latest revision level documentation necessary to define product configuration and control manufacturing processes. 
  • Timely distribution of latest revision level documentation to all appropriate users and ensure that obsolete documentation is removed from distribution. 
  • Perform clerical typing duties to generate documents as necessary. 
 
Requirements:
  • High School Graduate
  • 1+ years’ of relatable experience
  • Knowledge of FDA regulations, GMP, Six-sigma, lean, etc.
  • Good Communication skills
  • Problem-solving and decision-making skills
  • Location: Orange County
  • Type: Contract
  • Job ID: GL8447991130