Quality Assurance manager with demonstrated capacity to deliver and execute assigned audits and inspections of contractors and internal facility processes. Interested in expanding audit experience to additional areas including manufacturing quality assurance.Core performance attributes include leadership, communication, negotiation, conflict management and relationship building skills. Demonstrated capacity to network and collaborate across multiple teams with a positive attitude to accomplish results. Strong attention to detail with a keen eye for finding data or process discrepancies when auditing facilities, data and records.Proven track record for delivering facility and contractor audits of quality systems within set timelines. Quality audits and inspections experience include: data review, (multiple complex databases and data types), assessments of reports, computer system validation, personnel training, process documentation, audit trails, archival, standard operating procedures, internal audits, corrective action procedures and follow-up. Excellent working relationships with client groups, individual clients and QA management. Experienced trainer of on-the-job application of federal regulations to quality assurance colleagues, client groups, vendors and engineers and global colleagues.Avid learner, interested in acquiring new skill sets through course work, professional organizations and on-the-job training. Attendee of Society of Quality Assurance conferences and external university or courses for awareness of new technology and current regulatory guidances and expectations. Career mentor, part of formal corporate program, successfully encouraged employment development of colleagues.
Listed skills include Glp, Gxp, Fda, Sop, and 2 others.