Position Description

We are hiring a Change Control and Training Coordinator. The Change Control and Training Coordinator will process controlled documents through Document Control system and support the entire Quality System and Document Control program.

At FUJIFILM Irvine Scientific (dba 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 Irvine Scientific (dba 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

Responsibilities

• Administer Company’s Management of Change (MOC) Program. Evaluate, Coordinate, and monitor all changes involving product, process, equipment and facility changes.
• Ensure documentation completeness, traceability, and regulatory compliance.
• Collaborate with cross-functional teams to assess risk and define implementation plans.
• Manage and maintain company electronic training system, ensuring proper assignment and timely completion of training requirements.
• Develop Training Metrics, course curricula, and training compliance.
• Conduct and coordinate Quality System training for new employees.
• Maintaining Document Control system for the revision of controlled documents.
• Support GMP records management program.
• Support document control program.
• Support GMP labeling requirements.
• Support Quality Systems or Document Control department as Required

Required Skills/Education

• High school diploma or equivalent.
• A minimum of two (3) years’ experience of Quality Assurance, Quality Systems, or Document Control in a medical device manufacturing environment or equivalent.
• Computer skills, specifically MS Word, Excel, Outlook, Gmail
• Current industry regulations, e.g. cGMP, ISO 13485, 21 CFR Part 820, TGA and Canadian Medical Device Regulations.
• Ability to speak, write, and read English.
• Good oral and written communication skills.

Salary and Benefits:

• For California, the base hourly range for this position is $30.21 - $39.30. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off

*#LI-onsite       

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (fisihr@fujifilm.com).