QA Receiving Inspector

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 QA Receiving Inspector. The QA Receiving Inspector will be responsible for performing applicable sampling and inspection of incoming chemicals, components, and closures used in the manufacturing process and bacterial identification and growth promotion.

**

Responsibilities:

• Perform sampling and inspection of incoming chemicals, components, and closures used in the manufacturing process in accordance with approved procedures, raw material specifications and quality assurance program.
• Record data clearly and precisely using Irvine Scientific inventory management system and maintain inspection records.
• Maintain and update raw material inspection report database and prepare reports as assigned.
• Communicate with suppliers and purchasing as needed to collect raw material information.
• Work independently and have effective communication and organizational skills.
• Develop and write raw materials specifications.
• Accept/reject materials based on specifications.
• Assist in the release of final product.

Experience/ Education:

• High school or equivalent
• BS in a scientific discipline is preferred
• A minimum of two years of incoming inspection in a medical device, pharmaceutical, or biotech environment
• Computer skills necessary including Microsoft Word, Excel, Outlook. Experience with ERP/MRP system is a plus
• Current industry regulations, i.e., cGMP, QSR, ISO13485:2003, Canadian Device Regulations, Code of Federal Regulations, sampling plans, and general lab safety
• Ability to speak, read and write in English
• Good oral and written communication skills

FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.

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.