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|Quality System Specialist - Administrative|
|Hours:||40 Monday Friday 8AM to 5PM|
|Great career 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 all other departments and provides leadership for the development, maintenance, and continuous improvement of Quality System programs and processes.Leads the development, maintenance and continuous improvement of quality pro grams, processes and procedures.Responsible for interpreting policies, regulatory andor governmental regulations, and internal regulations to ensure compliance.Ensures Quality System policies, procedures and performances 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, and 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 auditinspection response and tracking.Leads recall related activities for customer communication, product returns and FDA reporting.Prepares and presents Quality System performance reports to senior management.
Minimum 3-5 years experience in pharmaceutical operations required. Basic MS Office. Basic knowledge of data analysis software and reporting, including Excel.
Bachelors degree preferred. Internal auditing experience a plus. Knowledge of Syspro ERP desirable.