QA SPECIALIST

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Replacement for maternity leave for 6 months.

CONTEXT

The Quality Assurance Specialist in Logistics and System Monitoring is part of the quality assurance team in Israel and reports to the Quality Assurance Systems and Equipment Team Leader. The Quality Assurance Specialist in Logistics and System Monitoring is responsible for quality activities related to the manufacturing process whether for research or applied (ISO 13485) products.

PURPOSE OF THE ROLE

• Ensuring adequate Quality System is in place within the systems monitoring procedures.
• Ensuring adequate Quality System is in place within the Logistics department including Packaging and shipment activities and procedures.
• Ensuring adequate Quality System is in place within the clean manufacturing areas activities and procedures.
• Ensuring ISO-9001, ISO 13485 are implemented as applicable.
• Supporting the Quality issues towards in- house as well as external customers.
  
  

• Quality of Water system: sampling, reports, trends, deviations, CAPA, change control etc.
• Quality of clean room environment: sampling, temperature and pressure monitoring, reports, trends, deviations, CAPA, change control etc
• Release of critical raw materials
• Supporting Technical Service department for complaints on products manufactured locally
• Control of change via Change control system
• Handling of deviations
• Internal and external audits performance
• Initiate, create and review relevant SOPs in the Documentation system (Procedures, Manufacturing Protocols, Specifications)
• Presenting Sigma-Aldrich Israel Quality system to customers (internal and external) when required
• Perform QA shop floor inspections in the production and packaging departments
• Perform other duties and responsibilities assigned by Quality Assurance Systems and Equipment Team Leader or by Quality Assurance Manager.