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Requisition Number 19-0001
Post Date 2/7/2019
Title Sr QA Specialist
City Mountain View
State CA
Description Responsibilities:
• Perform Document Control functions and administer changes in Document Management System
• Assemble and review batch records associated with clinical and commercial products, in-process materials and components
• Perform API and incoming components and final product sampling using alternate sampling plans as needed.
• Perform ROSS ERP System inventory transactions
• Manage Deviations/CAPA System
• Generate metrics and quality reports and maintain databases
• Conduct inspection of reserve samples
• Perform line clearance as needed and provide QA presence on the manufacturing floor to ensure compliance with the relevant standards, acceptance criteria, SOPs and cGMPs.
• Collaborate with Quality Control, Manufacturing, R&D, Regulatory, Engineering, and Supply Chain to ensure quality standards are met
• Participate in internal audits and regulatory inspections
• Review practices and provide recommendations for procedures and process improvements
• Perform other duties/responsibilities as assigned by the Quality Assurance Manager.

Requirements Skills Required:
• Knowledge of Good Documentation Practices and cGMP compliance for pharmaceutical and medical device products.
• Intermediate to advanced level knowledge of manufacturing equipment and processes.
• Ability to work in controlled, classified environment
• Proactive, self- motivated and initiative approach to work with a minimum guidance and supervision
• Strong communication , both spoken and written , interpersonal and negotiating skills to influence outcome and coordinate activities cross-functionally
• Effectively organize, prioritize and follow up on multiple requirements in a fast paced environment

Education:
• Bachelor’s degree in Science or related discipline or combination of education and experience

Experiences:
• Min. 5 years cGMP experience in Quality Assurance in the medical device, pharmaceutical or biotech industry compliant to U.S. FDA 21CFR820, 21CFR 210/211.
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