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Job #03340

About our client Our client is a well-established global brand in the area of medical device manufacturing. For over 2 decades the company has enjoyed solid growth through scientific innovation and superior service. This is a great opportunity for someone to join a company that offers a great corporate culture and is focused on the long-term development of its employees. Position Location Quality Assurance Director Colorado Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee entire QA activities of the company (including those of company projects in India) 2) Manage the operation and maintenance of GMP documentation system 3) Oversee auditing of contract manufacturers 4) Control clinical trial material release and distribution 5) Review QC testing 6) Conduct internal and supplier auditing 7) Investigate deviations and out of specification results 8) Review process batch records and release of final product 9) Manage the change control process 10) Oversee GMP training 11) Manage the stability-testing program 12) Review process validation protocols and reports 13) Support regulatory submission activities Requirements 1) MS/BS in Biological or Chemical Sciences 2) 10+ years of experience in a quality assurance environment 3) Experience in handling overseas projects a must 4) Biologics or biotech experience a plus 5) Knowledge of GMPs 6) Ability to work independently and set own agenda 7) Willingness to travel internationally (up to 30%)