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Quality Assurance - Clinical IPosted by: Sunrise Systems Inc.
Posted date: Mar-15-2017
Location: Andover, MA
Top 3 critical skills:
‚Ę Attention to Detail
‚Ę Strong Technical Writing
‚Ę Strong communication skills
Minimum education experience required: Bachelor of Science Degree
Provides project support with current Good Manufacturing Practices to support Raw materials and Supply chain operations. Provides guidance on procedures and training necessary to be in complete compliance with current GMPs. Years of Experience 0-3.
This position reviews and approves documentation associated with the supply, receipt, testing and release of raw materials and cell banks used in clinical and commercial manufacturing to ensure timely review and disposition of batches/lots.
‚ĘPerforms all work in compliance with cGMPs and site requirements.
‚ĘReview and approval of GMP documentation and their compliance to Client‚s Quality Standards.
‚ĘEnsure adherence to quality procedures, regulatory requirements and cGMPs.
‚ĘResponsible for the review and approval of records related to site‚s raw material program.
‚ĘProvide support to the supply, receipt, testing and release of Raw Materials and Cell Banks for use in Manufacturing
‚ĘReview and approval of Supplier and Material qualification.
‚ĘMaintain inspection readiness.
‚ĘSkilled at the use of Enterprise systems including, but not limited to site Quality Tracking System (QTS), Laboratory Information Management System (LIMS), SAP and Client‚s document repositories