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|Quality Systems Specialist|
|Hours:||40 Monday to Friday 8AM to 5PM|
|Great opportunity in Camarillo CA|
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. 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.Leads the development, maintenance and continuous improvement of quality programs, processes and procedures.Responsible for interpreting policies, regulatory andor 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 CAPAWorks 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 auditinspection response and tracking.Leads recall related activities for customer communication, product returns and FDA reporting.Prepares and presents quality system performance reports to
Minimum 3-5 years in quality manufacturing, project management, continuous improvement. Exp in CAPA and Root Cause Investigation. Basic MS Office Excel.
Bachelors degree preferred. Internal auditing experience a plus.