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Senior Technical Compliance Specialist

2 months ago

Santa Ana, California, United States FUJIFILM Holdings America Corporation Full time
Position Overview
FUJIFILM Holdings America Corporation is a global frontrunner in the development and production of cell culture media, reagents, and medical devices tailored for researchers and healthcare professionals.

Our organization is committed to delivering exceptional service and quality to scientists engaged in biopharmaceuticals, cell therapy, regenerative medicine, assisted reproductive technology, cytogenetics, and large-scale industrial cell culture for the production of biotherapeutics and vaccines.

We maintain strict adherence to ISO and FDA regulations, operating dual cGMP manufacturing facilities. Our consultative approach and expertise in cell culture and compliance empower our clients with unique capabilities and support. For over five decades, we have remained agile and focused on media, establishing ourselves as a strategic global leader in media products and services.

Job Summary
We are seeking a Senior Technical Compliance Specialist.

The Senior Technical Compliance Specialist will be tasked with ensuring product compliance in accordance with Standard Operating Procedures (SOPs) and Regulatory Affairs/Quality Assurance (RA/QA) requirements. This role encompasses responsibilities related to customer complaints, Corrective and Preventive Actions (CAPA), Quality Planning, and Facility Change Requests (FCRs).

Key responsibilities include participating in the customer complaint process, which involves complaint intake, documentation, leading assigned investigations, customer follow-up, and managing the tracking, trending, and reporting of Technical Investigations Program activities.

Core Responsibilities
  • Ensure prompt resolution and documentation of customer inquiries, providing timely and accurate solutions to technical challenges and addressing concerns raised by clients.
  • Collaborate with internal teams, including customer support, sales, and R&D, to deliver effective resolutions to customer inquiries.
  • Maintain the company's reputation as a technical resource and industry leader by fostering recognition among clients.
  • Drive continuous improvement in metrics related to productivity, customer satisfaction, and overall engagement.
  • Lead product compliance activities, including CAPA initiation, closure, and investigation support, as well as planning for Facility Change Requests.
  • Oversee compliant documentation intake, investigation oversight, and customer communication, ensuring timely closure of complaints, CAPAs, and Quality Planning activities.
  • Assist in communication with regulatory agencies regarding compliance activities.
Qualifications

A Bachelor's Degree with a minimum of 4 years of relevant experience in the medical device industry is required. Advanced degrees (Masters or PhD) are preferred and may count towards experience.

Five or more years of experience in Technical Support, Customer Service, Quality Assurance, or Regulatory Affairs in a medical device context is essential.

Familiarity with GMPs, CFRs, USP, ISO 13485, and other relevant standards is necessary, along with strong root cause analysis skills and proficiency in Microsoft Office applications.

Compensation and Benefits

We offer a competitive salary and a comprehensive benefits package, including medical, dental, vision, life insurance, a 401k plan, and paid time off.

FUJIFILM is an equal opportunity employer, committed to diversity and inclusion in the workplace.