Position Description

We are hiring a Quality Control Specialist I. The Quality Control Specialist will conduct testing on raw materials, in-process products, and final products to ensure material quality as well as to perform tests for monitoring environmental conditions and water quality.

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

• Testing on raw, in-process and final product
• Testing of environmental conditions to monitor regulated areas
• Testing of water systems to ensure water quality is maintained
• Verification and maintenance of instrumentation and methods as necessary
• Test material for investigations and deviations
• Execute testing methods for sterility, mycoplasma, host cell protein, HPLC analysis, SDS-PAGE and residual DNA testing
• Maintain and record data clearly and precisely
• Modification of standard operating procedures as necessary
• Coordinating samples for outsourced testing
• Documentation of all final products (Product Quality Control Profiles and management of data)
• Coordinating with other departments for sample submission
• Make product quality accept/reject determinations based on established specifications and quality standards and initiate Out of specification reports for nonconforming product
• Communicate to supervisor of OOS and deviations
• Prepare reports of results
• Preparation of buffers, general lab support and ordering lab supplies as needed

Required Skills/Education

• BA/BS degree in Biology, Molecular Biology, Cell Biology, Chemistry, Biochemistry or equivalent
• One year in pharmaceutical, biotech or academia lab environments
• Knowledge of Lab safety
• Basic understanding of 21CFR211 – cGMP, ISO 13485 and/or ISO 9001 with emphasis on laboratory testing, material specifications, and related areas.
• Ability to speak, read and write English well.
• Good oral and written communication skills.

 Benefits:

• 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).