QA Incoming Inspector

Quality Assurance | Santa Ana, CA

Job Description:

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.

Responsibilities:

  • 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. 

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Principals only. No recruiters please.

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.

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