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Sr. QA Specialist

Company: Astrix
Location: Newark
Posted on: November 20, 2022

Job Description:

Our client who is a clinical-stage biotechnology company is in search of a Sr. QA Specialist to join their fast growing team in Newark, CA. This is a great opportunity to be a part of a highly innovative organization, receive quality training, and work with state of the art equipment, systems and product.
Position: Sr. QA SpecialistLocation: Newark, CAShift Time: Monday-Friday. 32 hours a week
Objective: The position will be responsible for supporting quality management system and providing direction and decision-making regarding quality operations. Must be able to work independently and professionally in the execution of production.

  • Review production batch record for compliance to Good Documentation Practices and established SOPs/standards
  • Perform review of equipment qualification/validation Risk Assessments, Protocols/Reports and periodic reviews
  • Support QMS processes including deviations, CAPAS and change controls
  • Perform documentation review of media fills and media fill protocol approvals as needed
  • Create / revise documents (SOPs/Forms/templates) as needed
  • Write Quality procedures, policies, risk assessments, and training materials
  • Drives continuous improvement utilizing quality tools such as lean, six sigma, and risk management.
    • Bachelor's degree in Engineering, Chemistry or biological sciences required. Advanced degree preferred.
    • ASQ Auditor certification, ASQ Quality Engineer certification preferred.
    • At least 5 years in a technical role in quality assurance, manufacturing, QC or quality engineering with demonstrated manufacturing plant experience.
    • Direct experience with batch review and release of viral vector and/or cell therapy product lots preferred

Keywords: Astrix, Newark , Sr. QA Specialist, Other , Newark, California

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