Canon BioMedical, Inc. is dedicated to extending innovative Canon core technologies into the burgeoning life sciences field — and to the introduction and marketing of vital, new-platform products in the critical area of molecular diagnostics.
Canon U.S.A., Inc., is a leading provider of consumer, business-to-business, and industrial digital imaging solutions to the United States and to Latin America and the Caribbean markets. With approximately $29 billion in global revenue, its parent company, Canon Inc. (NYSE:CAJ), ranks third overall in U.S. patents granted in 2016† and is one of Fortune Magazine's World's Most Admired Companies in 2016. Canon U.S.A. is committed to the highest level of customer satisfaction and loyalty, providing 100 percent U.S.-based consumer service and support for all of the products it distributes. Canon U.S.A. is dedicated to its Kyosei philosophy of social and environmental responsibility. In 2014, the Canon Americas Headquarters secured LEED® Gold certification, a recognition for the design, construction, operations and maintenance of high-performance green buildings. To keep apprised of the latest news from Canon U.S.A., sign up for the Company's RSS news feed by visiting www.usa.canon.com/rss and follow us on Twitter @CanonUSA. For media inquiries, please contact firstname.lastname@example.org.
† Based on weekly patent counts issued by United States Patent and Trademark Office.
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Canon BioMedical is currently seeking a Senior Supply Chain Specialist to perform a variety of activities to ensure materials are tracked and traced as required per cGMP regulations, FDA regulations and ISO13485 guidelines. This position requires a high degree of responsibility and will be responsible for planning, purchasing, receiving, issuing and handling raw materials, intermediates and finished goods as well as packaging and shipping functions performed via established procedures. This position evaluates existing Supply Chain processes and systems, recommends and implements efficiencies, establishes new processes as needed, serves on new product development project core teams, and must be/become a Subject Matter Expert in our ERP system. This position requires an individual with the ability to multi-task, an attention for details, and the knowledge and understanding of working within a regulated environment. The position requires many internal and external interactions, attentiveness to customer needs, the ability to adjust to changes based on priorities, and good communication skills.
- Enters, maintains and analyzes the forecast.
- Runs and reviews MRP, obtains quotes and procures materials, schedules Production work orders.
- Leads supplier set-up; identifies vendors, manages Terms and Conditions through the Matter Management System, completes supplier set-up with vendors and maintains suppliers in ERP.
- Participates on new product development core teams, representing all of Operations.
- Verifies and maintains ERP data integrity.
- Audits suppliers and tracks suppliers’ performances.
- Manages the Return to Vendor process for materials that do not meet incoming specifications.
- Recognizes deviations of materials, facilities or procedures, evaluates possible cause of failure and recommends appropriate corrective measures.
- Exhibits Good Documentation Practices (GDP) with all documents and records in compliance with quality standards and FDA (21 CFR 820) regulations.
- Mentors, motivates and trains other supply chain personnel.
- Works with Quality Systems group to validate new supply chain equipment and place it into service.
- Works with contract manufacturing organizations and our distributors to ensure product realization and timely deliveries to customers.
- Creates, refines and/or reviews supply chain procedures and documentation.
- Leads efforts to establish, maintain and/or improve processes and procedures for materials management that meet internal standards and external regulatory requirements for products intended for clinical and commercial use.
- Provides supply chain guidance to all operational departments, R&D and business departments as needed.
- Serves as an ERP expert for the company.
- Mentors, motivates and trains other Supply Chain personnel.
- Provides input on materials management budget requirements.
- Leads or performs special projects on an as-needed basis.
- Requires a Bachelor’s degree in a scientific discipline with a minimum of 5 years in a Supply Chain role, and demonstrated working knowledge of materials management, electronic ERP systems, supplier controls and production related principles.
- Minimum of 2 years of regulated industry experience (In Vitro Diagnostic, Medical Device, Pharmaceutical or related) with cGMP, FDA regulations and/or ISO13485 standards.
- Experience with contract manufacturing organizations and distribution sites.
- Experience with MS Office and ERP/MRP systems (planning, materials maintenance, supplier functions and shipping).
- Must be able to work weekends, off-shifts and overtime as required, and able to lift 30 lbs.
- QAD Experience highly desired.
- APICS Certifcation highly desired.
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