Senior Quality Assurance Engineer

3 weeks ago


Mount Holly Springs, Pennsylvania, United States FUJIFILM Corporation Full time
Overview:

At FUJIFILM Diosynth Biotechnologies, we are seeking a highly skilled Senior Quality Assurance Engineer to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality of our biopharmaceutical products and processes.

Key Responsibilities:

• Partner with cross-functional teams to ensure quality oversight of drug product processes, including formulation, fill, and inspection.
• Develop and implement quality procedures and processes to ensure operational readiness and compliance with cGMP regulations.
• Conduct risk assessments and maintain oversight of change management processes to ensure manufacturing systems are validated and maintained in a validated state.

Requirements:

• Bachelor's degree in Life Sciences or Engineering with 9+ years of applicable industry experience, or equivalent combination of education and experience.
• 5+ years of experience in GMP Quality Assurance and/or similar role, with experience in validation, cGMP manufacturing operations, and/or quality oversight in an FDA-regulated facility.
• Prior experience with quality risk management principles, cGMP & FDA regulations, and cell culture processes is preferred.

What We Offer:

• Competitive salary and benefits package.
• Opportunities for professional growth and development.
• Collaborative and dynamic work environment.

How to Apply:

If you are a motivated and detail-oriented individual with a passion for quality assurance, please submit your application, including your resume and cover letter, to our website.

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