QA Specialist

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The Quality Assurance Specialist in QA Customer Facing and Internal Support Team is part of the quality assurance department in Israel and reports to the QA Team Leader. The Quality Assurance Specialist in QA Customer Facing and Internal Support Team is responsible for quality activities related to all products manufactured and/or processed by the Israel sites whether for research or applied (ISO 13485).

Key Tasks & Responsibilities

• Ensuring adequate Quality System in customer facing activities in place
• Ensuring adequate Quality System in place within internal quality assurance activities
• Ensuring ISO-9001, ISO 13485 requirements, are implemented as applicable.
• Supporting the Quality issues towards in- house as well as external customers.
  
  

• Supporting Technical Service department for questions/complaints on products manufactured locally
• Communication with customers and customer service units, initiating and follow up on SCAR were applicable.
• Monitor complaints status: reports, trends, deviations, CAPA, change control etc.
• Control of change
• Handling of deviations
• 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
• Management and completion of product shelf-life stability studies according to the local implementation requirements
• Write stability protocols and reports. Initiate, track, and monitor stability studies. Ensure all stability study failures are investigated.
• Perform QA shop floor inspections in the production and packaging departments
• Perform other duties and responsibilities assigned by the QA Team Leader or Head of Quality.
  
  

• Production, QC, Engineering, Maintenance, Warehouse and R&D departments.
  
  

• Services Suppliers
  
  

• Academic Degree (Bsc.) in Natural Sciences or Engineering (Chemistry, Biochemistry, Biotechnology or Microbiology).
• English: Technical (read/written/spoken)
  
  

• Previous industrial experience in ISO 13485 is an advantage.
• Previous experience in a computerized environment.
• Proficient Microsoft Office applications including Word, Power Point and Excel.
  
  

• Energetic and able to work in dynamic environments.
• Strong problem solving and analytical skills.
• Fluency in both written and spoken English.
• Excellent communication skills
• Good ability to work in teams
• Multitasking and time management abilities
• Detail oriented, excellent organizational and planning skills. The Quality Assurance Specialist in QA Customer Facing and Internal Support Team is part of the quality assurance department in Israel and reports to the QA Team Leader. The Quality Assurance Specialist in QA Customer Facing and Internal Support Team is responsible for quality activities related to all products manufactured and/or processed by the Israel sites whether for research or applied (ISO 13485).
  
  

• Ensuring adequate Quality System in customer facing activities in place
• Ensuring adequate Quality System in place within internal quality assurance activities
• Ensuring ISO-9001, ISO 13485 requirements, are implemented as applicable.
• Supporting the Quality issues towards in- house as well as external customers.
• AUTHORITY
• Supporting Technical Service department for questions/complaints on products manufactured locally
• Communication with customers and customer service units, initiating and follow up on SCAR were applicable.
• Monitor complaints status: reports, trends, deviations, CAPA, change control etc.
• Control of change
• Handling of deviations
• 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
• Management and completion of product shelf-life stability studies according to the local implementation requirements
• Write stability protocols and reports. Initiate, track, and monitor stability studies. Ensure all stability study failures are investigated.
• Perform QA shop floor inspections in the production and packaging departments
• Perform other duties and responsibilities assigned by the QA Team Leader or Head of Quality.
• MAIN INTERFACES
  
  

• Production, QC, Engineering, Maintenance, Warehouse and R&D departments.
• EXTERNALLY:
• Services Suppliers
• QUALIFICATIONS
  
  

• Academic Degree (Bsc.) in Natural Sciences or Engineering (Chemistry, Biochemistry, Biotechnology or Microbiology).
• English: Technical (read/written/spoken)
• PROFESSIONAL SKILLS & EXPERIENCE
• Previous industrial experience in ISO 13485 is an advantage.
• Previous experience in a computerized environment.
• Proficient Microsoft Office applications including Word, Power Point and Excel.
• PERSONAL SKILLS & COMPETENCIES
• Energetic and able to work in dynamic environments.
• Strong problem solving and analytical skills.
• Fluency in both written and spoken English.
• Excellent communication skills
• Good ability to work in teams
• Multitasking and time management abilities
• Detail oriented, excellent organizational and planning skills.