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QA Associate I

Location: La Jolla, CA, United States
Job # 11432930
Date Posted: 10-01-2018
QA Associate I
La Jolla, CA 
Pay rate: $22 hourly
Contract to hire 



Our client, a global leader in regenerative medicine related to advanced treatments in wound care and surgical biologics, is seeking a QA Associate I to assist with the review of batch records.

Responsibilities:
  • Perform Batch Record review of Batch records and Autoclave Runs.
  • Identify any discrepancies and find resolutions.
  • Performs Final Product Physical Disposition on a routine basis.
  • Works with the Manufacturing Department to resolve issues related to the review process.
  • Maintains metrics keep up-to-date status of progress and monthly performance.
  • Follows Product Release schedule.
  • Performs Device History Record scanning and filing for archiving.
  • Add to and revise standard operating procedures as required pertaining to QA product disposition activities.
  • Collaborate with different members of the QA Department working on special projects as needed.
Qualifications:
  • Must have a 4-year degree in a scientific discipline or equivalent experience.
  • 0-2 years of experience in GMP/GLP regulated environment.
  • Knowledge of regulatory standards: cGMP (21CFR820), QSR and ISO Standards requirements (ISO 13485:2003).
  • Experience with revising SOPs.
  • Able to prioritize and multitasking work activities. Possess excellent time management skills, be well organized, a self-starter and display a professional demeanor.
  • Excellent written and verbal communication skills.
  • Basic problem-solving techniques.
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