US-MD-Frederick: QA Specialist

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 10-Nov-2009

QA Specialist III

Job Functions: 1. Utilizes the QA system to assure compliance with cGMP regulations. 2. Works closely with QC and Development to facilitate the development and implementation of appropriate material specifications throughout the raw material life cycle, from clinical to manufacturing requirements. 3. Assists in the administration, review and approval of Change Control Documents, Deviations and CAPAs for assigned materials, as required. 4. Supports the evaluation and disposition of raw materials through timely compliance evaluation of material batch files, laboratory results and other cGMP documents. 5. Manages workflow to assure the timely supply of raw materials to commercial and clinical products. Employs metrics to identify and communicate potential schedule adherence issues and works towards their resolution. 6. Contacts suppliers as needed to address material concerns, assist in the implementation of SICs, and to provide appropriate support for the Supplier Audit Program 7. Facilitates conference calls with appropriate Medi personnel and suppliers as needed. 8. Creates and Coordinates appropriate trainings to facilitate the understanding of the raw material process company wide.

9. Serves as a QA representative for project teams. May assist in the management of small to medium sized projects impacting the QA department. 10. Investigates and assesses the impact of minor and major deviations that may pertain to raw material releases. Identifies root causes and recommends/implements corrective /prevent actions to avoid recurrence. 11. Reviews QC method protocols. 12. Supports other groups to complete annual product reviews. 13. Serves as a lead auditor for the Site Self Inspection Program, and assists in the preparation, execution and follow up activities related to Supplier Audits 14. Provides leadership and guidance to peers in the QA department and functional areas.

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Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com