Supervisor, QA
MedImmune - Frederick, MD

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Responsible for assuring the quality of licensed or clinical products manufactured at MedImmune or at contract manufacturing sites. The QA Supervisor supports and provides advice to a number of functional areas including manufacturing, facilities, IT, and other Quality departments. Interprets and implements quality procedures, manages quality systems and assists in maintaining site regulatory compliance documents and facilitating regulatory compliance inspections. Reviews 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. Supervises the activities of QA Specialists. Additional job functions *Utilizes the QA system to assure compliance with cGMP regulations.* Assists in the administration, review and approval of VSCRs, Deviations and CAPAs for assigned products, as required.* 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.* Manages workflow to assure the timely supply of commercial products and clinical materials. Employs metrics to identify and communicate potential schedule adherence issues and works towards their resolution.* Assists with the compilation and publication of quality metrics (e.g., "first time right") for Manufacturing, QC and QA activities. Uses the data to help drive quality improvement in documentation practices and production related activities.* Serves as a QA representative for project teams. May assist in the management of small to medium sized projects impacting the QA department.* Investigates and assesses the impact of minor and major deviations that may occur during the manufacture, testing or distribution of commercial products or clinical materials. Identifies root causes and recommends/implements corrective actions to prevent recurrence.* Reviews validation protocols and summary reports. * Supports other groups to complete annual product reviews.* Performs audits per the requirements of the self-inspection program.* Provides leadership and guidance to peers and direct reports in the QA department and functional areas.* Supervises the activities of other QA personnel. *Generates, reviews, and maintains site regulatory compliance documents


Minimum of 7 years related experience in a regulated (GxP / ISO) environment.

Education: BS life sciences

About this company
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MedImmune works to boost the immune systems of babies and grown-ups. Its flagship biotech product, Synagis, prevents respiratory syncytial...