Lead Technical Investigator

Overview

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, regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific, Inc. adheres to ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy and expertise in cell culture and compliance provide customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific, Inc. 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 a Lead, Technical Investigator. The Lead Technical Investigator will be responsible for engaging and ensuring appropriate product compliance in line with SOPs and RA/QA requirements, which includes tasks related to Complaints, CAPA, Quality Planning, and Facility Change Requests (FCRs). Participate in customer complaint and inquiry processes, including but not limited to, complaint intake, documentation and lead of assigned investigations, customer follow-up and management, and tracking, trending and reporting of Technical Investigations Program management and activities. Act as principle investigator on customer inquiries, complaint and/or CAPA investigations, as assigned, with support from cross-functional teams, and communicate directly with customers.

External US

Responsibilities

• Ensure quick resolution and documentation of customer inquiries. This includes providing timely and accurate solutions to customers' technical challenges, troubleshooting issues, and addressing any concerns raised by customers. Work collaboratively with internal teams, such as customer support, sales, FAS and R&D, to offer efficient and effective resolutions to customer inquiries. Moreover, the company's reputation as a technical resource and industry leader must be maintained, by playing a key role in building and fostering this recognition among customers.
• Drive continuous improvement for metrics for productivity, customer satisfaction and overall customer engagement.
• Act as lead, with support of cross-functional teams, to implement solutions to product issues or positioning, ensuring that timelines are met and customer satisfaction is achieved.
• Lead product Compliance activities, including, but not limited to, the following:
  • CAPA initiation, closure and investigation support of assigned CAPA owners
  • Review and planning for Facility Change Requests (FCR)
  • Writing, review and closure of Quality Planning Activities among all sites
  • Compliant documentation intake, investigation oversight, complaint review and approval, customer follow-up and communication, tracking, trending and reporting on program
• Determine the nature of direct and indirect customer inquiries, and classify them for resolution.
• Lead and monitor customer inquiries associated with complaints or CAPAs. Assist in coordinating cross-functional activities for Compliance activities.
• Ensuring timely and accurate closure of customer complaints, CAPAs, FCRs and Quality Planning activities and that established turnaround times are met.Ensuring compliance of processes and procedures to applicable standards related to Compliance activities, including but not limited to, complaints, CAPAs, FCRs and Quality Planning.                
• Assisting in the communication with regulatory agencies, notified body, and competent authorities as associated with Compliance activities.
• Revise or create Technical Support SOPs based on feedback and data, as needed.

Required Skills/Education

• Bachelor’s Degree with minimum 4 years of relevant experience in a medical device or related industry. Higher level educational degrees (Masters or PhD) are desirable and may count towards experience.
• Five (5) or more years of experience in Technical Support or Customer Service and/or Quality Assurance/Regulatory Affairs/Compliance, technical and customer support in a medical device discipline.
• GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC, ISO harmonized standards (EN14971, EN 13408, EN 13824).
• Quality control methodology, QA control systems and production methodologies.
• Experience in ART, Cytogenetics, cell and tissue cultures. Experience can be from educat