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Pharmaceutical company in Camarillo looking for a Quality Systems Specialist to join their team!Summary: Under the direction of the Manager of Quality Systems, the Quality System Specialist ensures compliance with Quality System requirements. The Quality System Specialist works collaboratively with personnel from other functional areas, such as, Packaging, Compliance, Procurement, Business Development, and Sales, in providing leadership for the development, maintenance, and continuous improvement of Quality System program and processes throughout GSMS. This includes, but is not limited to, Management Review, Change Control, Internal Audits, Training, Document Control, Record Retention, Product and Customer Complaints Handling, CAPA Program, which includes the Deviation, Corrective Action and Preventive Action (CAPA).Responsibilities: Leads the development, maintenance and continuous improvement of quality programs, processes and procedures. Responsible for interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Ensures Quality System policies, procedures and performance conform to regulatory requirements, standards, and guidelines. Owns and leads quality system processes performance and improvements; including, but not limited to, Management Review, Change Control, Internal Audits, Training, Document Control, Record Retention, Product and Customer Complaints Handling, Deviation reporting and investigations, Corrective Action and Preventive Action (CAPA) Works directly with internal and external suppliers and customers to ensure quality system requirements are met. Performs internal audits and inspections, including writing of audit report and presenting to upper management. Responsible for adherence to audit timelines and reporting. Assists with external audits of suppliers as needed. Responsible for managing customer and regulatory audits and inspections, including audit/inspection response and tracking. Leads recall related activities for customer communication, product returns and FDA reporting. Prepares and presents quality system performance reports to management.Cognitive Requirements: Strong working knowledge of FDA GMP regulations and quality system regulations/requirements Knowledge of manufacturing processes. Good communication skills at all levels, both written and verbal; both individually and in a group setting.Attitude: Must be enthusiastic, concerned with job and company as a whole, openness with management, and punctual. Self-discipline and a desire to achieve results. Must be flexible and willing to change. Must be detail-oriented. Team player, professional, and achieve high quality results.Top Skills:QA, Quality Systems, CAPAAbout Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
