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Requisition Number 18-0005
Post Date 4/12/2018
Title Sr Mgr Quality Assurance
City Mountain View
State CA
Description
Responsibilities:
• Responsible for management of the company’s Quality Assurance programs for our manufacturing operations including: Deviations, CAPA, SCAR, Change Control, Customer Complaints, Supplier Management
• Manage Document Control functions and administer changes in document management system
• Manage incoming materials and finished product sampling and disposition in Ross ERP system
• Participate in documentation reviews such as batch records, validation protocols and reports
• Manage the retain program
• Approve changes to controlled documents
• Provide QA expertise and guidance to resolve significant issues in compliance with cGMPs, in a fast-paced environment
• Recommend and implement improvements to QA procedures to assure cGMP compliance
• Perform external and internal audits
• Participate in regulatory inspections
• Identify key quality metrics, publish and monitor
• Participate in hiring, management, and development of QA personnel
• Collaborate with cross functional groups
• Notify Management of potential quality and regulatory issues that may impact product quality or regulatory compliance

Requirements
Skills needed:
• Management experience
• Knowledge of cGMP documentation practices, cGMP compliance for pharmaceutical and medical device products, Quality principles, and industry practices
• Strong attention to detail
• Familiarity with manufacturing equipment and processes
• Experience with inhalation products is a plus
• Planning and organizational skills to handle multiple priorities effectively, resource constrains and tight timelines
• Strong verbal, written technical and interpersonal communication skills
• Ability to interact at all levels to influence outcome cross-functionally
• Ability to exercise judgment within defined practices, policies, and company objectives in order to evaluate and solve problems
• Ability to use sound analytical methods for making decisions that may impact product and cross functional success
• Ability to resolve problems ranging in scope from moderately complex to complex where analysis of situations or data requires in-depth evaluation of various factors

Education:
• BS/BA in physical/chemical/biological sciences with at least 10 years of experience in cGMP environment for the medical device, pharmaceutical, or biotech industry, and min. 5 years in QA role

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