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Quality Assurance Manager Saint Paul United States,  

Posted on : 13 May 2017

Project Description

We are seeking a QA Manager to join our North American headquarters in St. Paul, Minnesota.As QA manager, you will: " Oversee all quality aspects with the aim of contributing to the organization s strategy " Translate strategy into quality in actual projects utilizing generally accepted quality standards (including ISO standards, corporate TQM, GMP, GDP, etc.) to achieve continuous improvement. " Manage a small QA team " Guarantee quality within the complete flow from raw material to product and continuously strive to achieve optimum quality. " Assure adequate control and documentation of controlled substances, per state and DEA regulations. " Follow all federal, state and local laws, rules and regulations for quality and safety in the preparation compounded medications " Interact regularly with federal and state agencies (FDA and DEA primarily) and serve as the contact for suppliers, customers and local authorities on the subject of quality. " Manage and process complaints (CAPA) " Draft and review validation protocols " Draft and review SOP s and other elements of the quality system " Analyze and report on the results of quality controls, and prepare, manage and follow up on audits Set yourself apart You possess the following qualifications, background and abilities: " Pharmacy degree preferred, but not required " Experience working within GMP standards is preferred " 3+ years of experience in a quality department, ideally working on an international scale " CAPA and/or root cause analysis experience is ideal " Experience working and coordinating with analytical testing labs " Formulation, product release and patient safety experience " Experience in retail and/or hospital pharmaceutical market " Knowledge of principles, theories and laws, policies and procedures relating to pharmacy operations " Experience in managing a team is preferred, but not required " Technical ability, analytical ability, and decisive judgment " Self-motivated with a strong work ethic What s on offer? Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.


St. Paul , United States

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