Occupation:Clinical Quality Assurance |
Location:Hayward, CA |
Education Level:Master |
Will Relocate:YES |
Description
Summary * Multiple years' experience and thorough understanding of technical and business requirements for Biotech in clinical and commercial multi-product manufacturing facility. * Knowledge of regulatory expectations and requirements for protein purification facilities and industry standards and practices, manufacturing processes, cleaning validation, safety principles, quality systems, cGMPs, engineering design fundamentals, and industry trends, Validation Lifecycle approach. * Hands-on experience working with Cell Culture and Purification equipment (CHO and E-Coli) with sound knowledge of aseptic processing and supporting technologies and Cleaning Validation in multi-product facility. * Hands-on experience working with Autoclaves, Centrifuges, automated cleaning (CIP) and Steaming (SIP) systems and Continuous Process Monitoring Systems. * Continuous process improvement experience such as Operations Excellence. * Supported regulatory inspections and filings and have a good understanding of quality systems such as Quality/Change Control, Contamination Responses, Deviation/CAPA, Production Controls, Material Controls, Facilities/Equipment Controls, Six Sigma and Kaizen. * Ability to organize and manage projects, work independently or in large and small cross-functional teams, with focus on Continuous Improvement initiatives. * Possess strong technical writing, project management, verbal communication, troubleshooting, and problem solving skills. * Reporting and/or software updates and revalidation to improve the overall accuracy, efficiency, and effectiveness of QMS systems (Trackwise and SAP) * Assist in creating end user trainings, SOP and other materials for TrackWise and SAP applications (Quality Management Systems). * Knowledge and experience with improvements of QMS software systems (i.e. TrackWise, SAP). * Strong understanding of the current pharmaceutical industry and applicable regulations. * Experienced in quality systems, technology transfer, scale up and validation. * Hands on experience and knowledge of equipment, facility, process and software validation * Strong knowledge of applicable Quality Systems and current Good Manufacturing Practice (cGMP) requirements (FDA, EU, ICH) with the ability to assess compliance risks.
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