QC Manager - Job ID:4739

Duties:

  • Will manage data review, analysis, assay troubleshooting, and implement improvements.
  • Review QC SOP's and validation protocols as well as prepare, execute, and review deviations, change controls, CAPAs, OOT/OOS.
  • Will lead QC activities for technology transfer of manufacturing and testing processes to external CTOs.
  • Manage release and stability testing for starting materials and drug product.
  • Will prepare and review CMC sections of regulatory filings.

 Background: 

 

  • Bachelors Degree and 5+ years QC experience.
  • Experience with technology transfer and CTO/CMO management.
  • Must have lead and/or supervisory experience.
  • General knowledge of manufacturing for gene therapy preferred.
  • Strong knowledge of cGMP/ICH/FDA/EU regulations.

 

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.


Commonwealth Sciences, Inc.
http://www.cwsciences.com

 

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