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QA Incoming Inspector

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 for a QA Incoming Inspector. The QA Incoming Inspector will be responsible to ensure quality of product by performing inspections of product, personnel, and processes real time with manufacturing production. This individual will collaborate and coordinate manufacturing issue resolution, through questions, meetings, documentation and follow up of actions. Review, obtain corrections, and completed actions to release batch records postproduction. - - **

External US


  • Perform inspection activities (product, performance, training) in the manufacturing areas
  • Convene and coordinate deviation management activities
  • Follow and enforce GMP principles and company policies and procedures throughout the organization
  • Perform facility walkthroughs to ensure company procedures are followed report any deviation immediately to department management.
  • Built a collaborative and communications report with operations management
  • Attend daily production meetings and address production issues and report accordingly Review batch production records and perform associated activities (CoA's, DB's, error correction)
  • Inspect labeling and storage conditions of product
  • Assist in the updating of controlled documents (generating DCRs as needed)
  • Reviews and provide proposals for processes improvements as needed Maintain and update raw material inspection report database and prepare reports as assigned.
  • Work independently and have effective communication skills.
  • Accept/reject materials based on specifications.
  • Assist/perform the release of final product.Experience/ Education:
    • High school diploma or equivalent; basic understanding of microbiology and chemistry necessary
    • Minimum of two years of college or BS in a science discipline is preferred
    • A minimum of two years of Quality Assurance (record review or incoming inspection) in medical device manufacturer or equivalent
    • Computer skills necessary including Microsoft Word, Excel, PowerPoint, ERP systems
    • Detailed understanding of Current industry regulations, i.e., cGMP, FDA QSR 820, ISO13485, Canadian Medical Device Regulations, inspection guidelines, and general lab safety.For California, the base salary range for this position is $23.00 to $29.00 hourly. 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 , QA Incoming Inspector, Other , Santa Ana, California

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