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Quality Assurance Incoming Inspection Lead

Company: FISI - FUJIFILM Irvine Scientific
Location: Santa Ana
Posted on: March 17, 2023

Job Description:


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 Lead. The QA Receiving Inspector Lead oversees and performs applicable sampling and inspection of incoming chemicals, components, and closures used in the manufacturing process and bacterial identification and growth promotion.

External US


  • Provide work direction to and supervision of the QA Receiving Inspectors.
  • 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 Fujifilm 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 -For California, the base salary range for this position is $71,000 to $115,000 annually. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).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.If COVID-19 -vaccine is mandated by the federal government, or by state or local government, the Company -will -require that the successful candidate hired for positions -covered under relevant government vaccine mandate(s) -be fully vaccinated against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption. - For all -positions, the Company -encourages vaccination against COVID-19 and -may require that the successful candidate hired be willing to test for the COVID-19 virus -periodically -and wear a face covering indoors absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption. - -

Keywords: FISI - FUJIFILM Irvine Scientific, Santa Ana , Quality Assurance Incoming Inspection Lead, Other , Santa Ana, California

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