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Qa Incoming Inspector Jobs

Company

FUJIFILM

Address , Santa Ana, Ca
Employment type
Salary $23 - $29 an hour
Expires 2023-06-25
Posted at 1 year ago
Job Description
Overview:
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:
Responsibilities:
  • Convene and coordinate deviation management activities
  • 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)
  • Built a collaborative and communications report with operations management
  • Accept/reject materials based on specifications.
  • Follow and enforce GMP principles and company policies and procedures throughout the organization
  • Reviews and provide proposals for processes improvements as needed Maintain and update raw material inspection report database and prepare reports as assigned.
  • Inspect labeling and storage conditions of product
  • Assist in the updating of controlled documents (generating DCRs as needed)
  • Perform inspection activities (product, performance, training) in the manufacturing areas
  • Assist/perform the release of final product.
  • Perform facility walkthroughs to ensure company procedures are followed report any deviation immediately to department management.
  • Work independently and have effective communication skills.
Experience/ Education:
  • Minimum of two years of college or BS in a science discipline is preferred
  • High school diploma or equivalent; basic understanding of microbiology and chemistry necessary
  • Detailed understanding of Current industry regulations, i.e., cGMP, FDA QSR 820, ISO13485, Canadian Medical Device Regulations, inspection guidelines, and general lab safety.
  • Computer skills necessary including Microsoft Word, Excel, PowerPoint, ERP systems
  • A minimum of two years of Quality Assurance (record review or incoming inspection) in medical device manufacturer or equivalent
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.