We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.
We are seeking a highly motivated individual to join us as a Senior QA Technical Specialist in our Contract Manufacturing site located in Research Triangle Park, NC. The position acts as the subject matter expert for multiple or complex Quality Assurance systems and compliance activities. Under limited supervision, the Senior QA Technical Specialist assists to establish and meet quality and compliance requirements in Multiple Compliance Areas.
Irvine Scientific, a member of Fujifilm Holdings Corporation, is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in cell therapy and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large- scale production of biotherapeutics and vaccines. Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 45 years, Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services. Additional information can be found at www.irvinesci.com.
We are hiring for a Sr. Regulatory Affairs Specialist. The Sr. RA Specialist will assist and coordinate the compiling, preparation and assembly of regulatory submission and support files for medical devices and in vitro diagnostics registration worldwide in accordance with GMP, ISO 13485, MDD 93/42/EEC, IVD D 98/79/EC, ISO 14971, Canadian Medical Device Regulation, and related country regulations for medical devices and in vitro diagnostics. Such activities include: Technical Files, Risk Management, FMEA, Essential Requirements, outside references and various regulatory external and internal support as required. In addition, the Sr. RA Specialist will support both direct registration efforts and registration efforts made on behalf of the company by a qualified third party (i.e. Distributor).This person will also ensure that requirements are met in all regulatory and registration functions as prescribed by the FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada MDR and related medical device and in vitro diagnostics requirements in all countries where product is registered and distributed.
Sr. QA Specialist - Bothell, WA
FUJIFILM, SonoSite, Inc . We are an innovative and high performance culture with tremendous opportunities. People who work here are given the unique opportunity to contribute to the advancement of healthcare throughout the world. Headquartered in Bothell, WA USA, FUJIFILM SonoSite is represented by a global distribution network in over 100 countries. Since its inception, FUJIFILM SonoSite’s lightweight, robust products have created and led the point-of-care ultrasound market. From sophisticated urban hospital emergency rooms to clinics in austere, remote villages, FUJIFILM SonoSite systems are used by over 21 medical specialties and provide clinicians around the world with a cost-effective tool for improving patient safety and workflow efficiency. FUJIFILM SonoSite holds a number of prestigious design awards and has in excess of 145 patents.