Sr Technical Investigations Specialist

Fujifilm•Irvine, CA

11d•$82,353 - $107,363•Onsite

About The Position

We are hiring a Senior Technical Investigation Specialist. The Senior Technical Investigation Specialist will engage and ensure appropriate product compliance in line with SOPs and RA/QA requirements, which includes tasks related to Complaints, CAPA recommendations. They will 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. They will also act as senior level investigator on customer inquiries, complaint and/or CAPA recommendations, as assigned, with support from cross-functional teams, and communicate directly with customers. At FUJIFILM Biosciences, we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world’s biggest health challenges. Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you’re ready to make an impact, your future belongs with us at FUJIFILM Biosciences. Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Requirements

B.S. or B.A. in scientific discipline preferred.
Three (3) 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 cell and tissue cultures. Experience can be from education or industry.
Ability to obtain cooperation from other groups and act as principal in cross functional teams.
Experience with risk management and Failure Mode Effects Analysis (FMEA).
Strong root cause analysis skills required.
Proficient in Microsoft Word, Excel, PowerPoint, Outlook.
Mammalian Cell & Tissue Culture; Biochemistry, preferred
Leadership; Decision Making.
Communications Proficiency; Presentation Skills.
Ability to analyze situations with strategic and creative thinking skills.
Ability to speak, read and write English proficiently.
Additional language skills are preferred.
Good oral and written communication skills

Nice To Haves

Mammalian Cell & Tissue Culture; Biochemistry, preferred
Additional language skills are preferred.

Responsibilities

Act as senior level investigator on all assigned tasks
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 senior level responsible individual, with support of cross-functional teams, to implement solutions to product issues or positioning, ensuring that timelines are met and customer satisfaction is achieved.
Perform product Compliance activities, including, but not limited to, the following:
CAPA evaluation
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.
Ensuring timely and accurate closure of customer complaints and Technical Investigations 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 and Technical Investigations