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 a Product Compliance Specialist III. The Product Compliance Specialist II perform, execute and manage, Quality System product compliance tasks related to Complaints, CAPA, Quality Planning, and Facility Change Requests (FCRs). Manage customer complaint process, including but not limited to, complaint intake, documentation and investigation, customer follow-up, tracking and trending. Lead and manage complaints investigations internally and communicate directly with customers. Lead and manage CAPA investigations, Quality Planning and FCRs.
+ Manage and perform 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
+ Complaint documentation intake, investigation oversight, customer follow-up, tracking and trending
+ Determine the nature of direct and indirect customer inquiries, and classify them for resolution.
+ Managing and monitoring customer inquiries associated with complaints or CAPAs. Managing and 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.
+ S. or B.A. in scientific discipline preferred.
+ Two (2) or more years of experience in 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 cell and tissues culture. Experience can be from education or industry.
+ Ability to obtain cooperation from other groups and lead cross functional teams.
+ Experience with risk management and Failure Mode Effects Analysis (FMEA).
+ Strong root cause analysis skills required.
+ Ability to speak, read and write English proficiently.
+ Good oral and written communication skills
+ Proficient in Microsoft Word, Excel, PowerPoint, Outlook.
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.
Requisition ID: 2022-20266
External Company URL: https://uscareers-fujifilm.icims.com
Street: 1830 E Warner Ave