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