Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
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!