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Job #03307

About our client Our client is headquartered in Washington and is a leading contract manufacturer serving the pharmaceutical and medical device industry globally. The organization has some of the strongest financial indicators in the industry and a world-class program for ongoing employee development. This is an incredible opportunity for someone that wants to put their drive and initiative to work. Position Location Quality Assurance Manager Washington Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee calibration and testing programs 2) Supervise the Quality Assurance Specialists Group 3) Prepare regulatory submissions (as required) 4) Interact at all levels of the organization to ensure compliance with quality policies, goals and objectives 5) Assist the Management Team (as necessary) 6) Ensure compliance with all applicable FDA regulations 7) Analyze customer and regulatory requirements to assess the effect on internal as well as established quality systems 8) Assist in developing compliant procedures and quality systems 9) Prepare for and lead the Quality Assurance Team through external audits 10) Oversee process and cleaning validation development including appropriate acceptance criteria 11) Assist in developing installation, operational and performance qualifications for both process and lab equipment 12) Perform internal audits 13) Address non-conformances from internal or external audits 14) Oversee proper training program development 15) Design, implement and administer appropriate document controls 16) Administer corrective action systems 17) Stay up-to-date with domestic and international regulatory changes, specifically India 18) Participate in filing NDA, ANDA, 510ks, annual reports, etc. Requirements 1) Bachelor’s degree in a scientific field (Chemistry, Biochemistry or Engineering) 2) Minimum 10 years of experience in QA/RA related to the pharmaceutical industry 3) Experience in and strong knowledge of FDA regulations (CFR 210, 211 & 820 and Q7A) 4) Experience in FDA audits and PC-based computing 5) Oriented towards quality with high attention to detail 6) Excellent communication (written and verbal), organizational, managerial and interpersonal skills