Quality Assurance Inspector

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Job description

Quality Assurance Inspector, Irvine, CA
Apply to join a worldwide leader in biopharmaceutical, cell therapy, regenerative medicine and biotherapeutics as a QA Inspector!

Responsibilities

• Ensure quality of product by performing inspections of product, personnel, and processes real time with manufacturing production. 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 post production.
• 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 (CoAs, DBs, 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.

Education and Experience:

• 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 (2) 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.

Schedule: M-F 1pm - 9:30pm

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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