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Quality Assurance Analyst Jobs in California

Quality Engineer

EliteProTek

  • Oceanside, California
  • 21 days ago

    Highlights

    80% - Responsible for day-to-day QE activities including support of OOS, deviations, CAPA and change control documents, and Quality Engineering support of production activities. Experience with gathering pertinent data, preparing narrative reports, statistical reports, charts, graphs, and tables.

    Numbers & Facts

    LocationOceanside, California

    Description

    Qualifications:
    • Bachelor of Science Degree
    • 2 years of GMP experience and knowledge about GMP QE
    • Support Commissioning, Qualification, and Validation activities
    • Maintain Process/Equipment reliability programs including a Total Preventive Maintenance
    • Experience with federal regulations regarding GLP and GMP
    • Experience with gathering pertinent data, preparing narrative reports, statistical reports, charts, graphs, and tables
    • Knowledge of FDA Good Laboratory Practice, Good Tissue Practice and Good Manufacturing Practice guidelines
    • Demonstrated ability to develop and monitor quality improvement plans and SOPs
    Responsibilities:
    • Responsible for supervising other QA officers providing training and guidance in day-to-day Good Manufacturing Practices (GMP) compliance activities
    • Responsible for training and providing guidance to other staff and facility users/clients
    • Expected to report regularly and provide updates to Quality management
    • 80% - Responsible for day-to-day QE activities including support of OOS, deviations, CAPA and change control documents, and Quality Engineering support of production activities
    • Responsible for writing, review, and approval of technical assessment of Master Production (batch) Records, Standard Operating Procedures (SOPs), worksheets, forms, Specifications, Validation Protocols and reports, and Production Record Control systems to ensure compliance

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