FUJIFILM Irvine Scientific, Inc., 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 biopharmaceuticals, cell therapy, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM 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 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services. FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.
We are hiring for a Technical Support Scientist. The Technical Support Scientist will provide technical support to internal departments, field employees and external customers. In addition, this person will assist with processing and resolving technical issues, complaints, corrective action preventive action (CAPA) and regulatory submissions. The Technical Support Scientist will also assist with design changes and review of risk analyses files as needed.
This position receives and processes customer inquiries and complaints and will document and convey this information to the appropriate functional department for resolution. In addition, the TSS will lead the activities related to resolving complaints, assessing corrective action, and corrective action preventive action (CAPA).
External US Responsibilities:
- Determine the nature of direct and indirect customer inquiries, and classify them for resolution
- Serve as a resource for R&D and commercial groups to support product evaluations by keeping the focus on technical resolution with in-house groups
- Assist in process improvement projects to improve effectiveness and efficiency of process directly affecting our customers and their adaptation of our products
- Analyze product evaluations for performance and technical trends to enhance our technical response to issues and to realize opportunities
- Manage and monitor customer inquiries associated with complaints
- Manage and coordinate cross-functional activities for corrective/preventive action program
- Ensure timely closure of customer complaints and that established turnaround times are met
- Ensure processes and procedures comply with applicable standards related to complaints
- Provide technical support, as needed, for the preparation of regulatory submissions for FDA/EU/CMDR or other regulatory agencies
- Assist with changes to product design, specification or production processes and review risk analysis files as required
- Assist in the communication with regulatory agencies, notified body, and competent authorities as associated with complaints
- Develop materials (e.g. FAQs) to reduce the number of recurring inquiries on products
- MS in Life Science field or equivalent
- 2 or more years of experience in Quality Assurance/Regulatory Affairs, technical and customer support in a medical device discipline preferred
- 2 or more years of experience in cell biology and/or tissue culture
- 2 or more years of experience in Cell Therapy, Gene Therapy, or Bioproduction
- Knowledge of GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC, ISO harmonized standards (EN14971, EN 13408, EN 13824) preferred
- Knowledge of quality control methodology, QA control systems and production methodologies preferred
- Ability to obtain cooperation from other groups and lead cross functional teams
- Experience with risk management and Failure Mode Effects Analysis (FMEA) preferred
- Strong root cause analysis skills required
- Proficient in Microsoft Word, Excel, PowerPoint, Outlook
FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.