Responsible for assuring the quality of clinical products manufactured at MedImmune
The Specialist supports a number of functional areas including manufacturing, factilities and other Quality departments. Implements quality policies, manages quality systems and assists in facilitating regulatory compliance inspections. Utilizes Operational Excellence tools such as FMEA, DMAIC and root cause analysis. Quality at the source utilizing on the floor real time review and investigations. Review documents such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, technical reports, etc., that are submitted to QA for approval.
Utilizes quality assurance system in compliance with current good manufacturing practice regulations. Administers the change control and Deviation and corrective action systems for assigned products and quality systems. Maintains database; generates standard and ad hoc reports. Manages workflows to assure timely supply of commercial product. Supports the evaluation and disposition of labeling, raw materials, intermediates and finished products through timely compliance evaluation of batch records, laboratory results and other cGMP documents. Investigates and assesses the impact of minor and major deviations that may occur during manufacture, testing or distribution of products or during the administration of quality systems. Identifies root causes and recommends and implements corrective actions to prevent recurrence. Performs trend analysis to monitor process and facility performance. Employs metrics to track the performance of operations and quality systems. Reviews validation protocols and summary reports. Supports other groups on completion of annual review and annual product reports. Performs in-plant inspections of active production areas to resolve problems early and to ensure compliance with SOP and regulatory requirements.
Education and Experience
B.S. in Biology, Chemistry, Engineering or related fields. 3+ years experience.
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