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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.

KEY TASKS & RESPONSIBILITIES

• 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.

MAIN INTERFACES


INTERNALLY:

• Production, QC, Engineering, Maintenance, Warehouse and purchasing departments.

EXTERNALLY:

• Raw material and equipment suppliers
• Services Suppliers
• External regulatory Auditors
• Global Technical support group

QUALIFICATIONS

EDUCATION/LANGUAGES

• 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 an ISO 9001/13485 or GMP environment is an advantage.
• Previous experience in a computerized environment.
• Proficient Microsoft Office applications including Word, Power Point and Excel.

PERSONAL SKILLS & COMPETENCIES

• Leadership and good interpersonal skills.
• 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.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!