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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

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

  • 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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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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