Quality Assurance Specialist, 2nd shift
Randstad is seeking a Quality Assurance Specialist for a contract assignment at one of its biotechnology clients. This client is a leading developer, manufacturer, and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood, and aid in biomedical research. You will work in an atmosphere that is stimulating, innovative, and customer focused.
- Performs batch record review of less complex documentation for finished products such as subassemblies, bulks, labeled reagents and kits.
- Performs approval and final release of less complex documentation for finished products such as subassemblies, bulks, labeled reagents and kits using the EDMS and ERP system.
- Conducts compliance audits of less complex documentation & data.
- Assists in internal and/or walk around audits.
- Serves as QA interface with limited responsibilities.
- Prepares data packages for external customers and regulation bodies.
- Performs compliance activities such as QA Holds, room releases, at-risk processing, etc.
- Assists in new employee training.
- Performs initial troubleshooting activities.
- Assists in maintenance & reporting of department metrics.
- Review and assess the appropriateness of document changes in accordance with internal procedures with oversight and guidance.
- Inspects raw materials, components, and finished kits.
- Maintains inspection and lab records.
- Perform laboratory maintenance per written protocols (e.g. cleaning, equipment and maintenance calibration).
- Identifies and performs general process improvements for productivity, quality, or safety.
Working hours: 2:00 PM - 10:30 PM
- Learning Skills
- Communication skills
- Typically requires High school and 4-6 years related experience or AA and 2-4 year related experience or BS and 0-2 years related experience
- Basic knowledge of QSR & ISO requirements
- Basic computer skills
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