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QA Specialist

Newark, CA 94560

Posted: 09/20/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 586074 Is job remote?: No Country: United States

Job Description


Responsibilities include, but are not limited to:
  • Review production batch record for compliance to Good Documentation Practices and established SOPs/standards Initiate raw material and product disposition process
  • Assist with QA retain inspections w/ QC and Sample Mgmt. Review and approve
  • Certificate of Analysis and Certificate of Conformance for batch release
  • Perform documentation review of media fills and media fill protocol approvals as needed
  • Create / revise documents (SOPs/Forms/templates) as needed
  • Support QMS processes including deviations, CAPAS and change controls
  • Assist with training other individuals within the department
  • Review specifications/ standards/ inspection plans for compliance to current regulatory requirements.
  • Participate in audits as assigned by management
  • Other duties as assigned by supervisor


Skills:    
  • Knowledge of quality systems and regulatory requirements including relevant US and EU guidelines


Education:    
  • Bachelor’s degree in related science or engineering field with at least 5 years of experience in GMP regulated biopharmaceutical manufacturing with preference for experience with gene and cell therapy products




Pay Rate Range: $40-58/hr. Salary will be commensurate with experience.
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