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Job #03104

About our client Our client, located in South Carolina, is a leading contract manufacturer that services the pharmaceutical and medical device industry. The company has an experienced management team, solid financials and an empowering culture that is focused on the long-term professional development of its employees. Position Location Quality Assurance Manager Piedmont, South Carolina Salary Highly competitive package, commensurate with experience Responsibilities 1) Ensure compliance with all applicable FDA regulations 2) Analyze customer and regulatory requirements to assess effect on internal/established quality systems 3) Assist in developing compliant procedures and quality systems 4) Prepare for and lead the Quality Assurance Team through external audits 5) Oversee process and cleaning validation development including appropriate acceptance criteria 6) Assist in developing installation, operational and performance qualifications for both process and lab equipment 7) Perform internal audits 8) Address non-conformances from internal or external audits 9) Oversee proper training program development 10) Design, implement and administer appropriate document controls 11) Administer corrective action systems 12) Oversee calibration and testing programs 13) Supervise the quality assurance specialists group 14) Prepare any regulatory submissions (as required) 15) Interact at all levels of organization to ensure compliance with quality policies, goals and objectives 16) Assist in project meetings 17) Maintain confidentiality 18) Assist management team (as necessary) 19) Stay current with domestic and international regulatory changes Requirements 1) Bachelor’s degree in a scientific field (e.g. Chemistry, Biochemistry or Engineering) 2) Minimum 10 years of experience in QA/RA related to the pharmaceutical/medical device industries 3) Experience in and strong knowledge of FDA regulations (i.e. CFR 210, 211 & 820 and Q7A) 4) Experience in FDA audits 5) Experience in PC-based computing 6) Participate in filing NDA, ANDA, 510ks, annual reports, etc. 7) Excellent communication skills (written and verbal) 8) Good organizational and managerial skills 9) Superb interpersonal skills 10) Oriented towards quality with high attention to detail