The Qualilty System Specialist is responsible for general support and maintenance of the Quality System within the requirements of FDA's Quality System Regulation (QSR) and ISO 13485:2003 (ISO), specifically, functions including support of manufacturing and process improvement, record review, product release and document control.
This is a regular part-time position (25-30 hours per week) providing coverage for the weekend shift (Saturday and Sunday) and during a portion of the work week.
- Review records and documents, for completeness and compliance with QSR and ISO requirements.
- Review batch record to support release of raw materials, work in progress and final products. This includes reagents, components and instrumentation-related products.
- Assist with the implementation of standard operating procedures to define and improve quality system functions.
- Support the Material Review Board, for the assessment and disposition of non-conforming materials.
- Support interdepartmental initiatives for continuous improvement.
- Partner with departments to promote improvements, through the use of training and coaching.
- Support the corrective action program in the investigation and resolution of issues.
- Support the Agile electronic documentation process, as needed.
- Participate in the internal auditor program, as needed.
- Bachelor's Degree in scientific, quality system or a related discipline. Or, equivalent combination of education and experience to perform at this level.
- 2 to 4 years of practical experience in a regulated manufacturing environment.
- Excellent verbal and written communication skills in group or one-on-one settings.
- Computer skills, e.g., Word, Excel, Access, Microsoft Project, electronic documentation systems, ERP systems.
- Ability to interface well with people of varied backgrounds, and to guide groups toward effective dynamics.
- Understanding of general mathematical principles and calculations, at college entry level.
- Understanding of SPC techniques.
- Experience in compiling data to support metrics analyzing current process.
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