QA Engineer - Fujifilm

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, 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 ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy and expertise in cell culture and compliance provide 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 a Quality Assurance Engineer. The Quality Assurance Engineer will lead Quality System improvements as well as drive resolution of deviations and product nonconformance. The role involves identifying and implementing efficiencies, leading risk assessments, managing quality-related customer support, and ensuring compliance with ISO 9001 requirements. Oversee and ensure that required quality exists in all Quality Assurance & Validation functions as prescribed by the ISO 9001 and GMP requirements.

Responsibilities

• Perform and assist with incoming inspection, batch records, documentation, training, batch release, validation, deviation, complaint, investigation, continuous improvement, and system reviews.
• Assist with document creation, revision, issuance, and training.
• Support internal, customer, supplier, and regulatory audits.
• Review and release raw materials, intermediates, and final products.
• Lead and execute validation activities.
• Manage trend reviews, data reviews, KPI management, and continuous improvement projects.
• Assess, investigate, and verify information related to non-conformances.
• Drive continuous improvement within the organization, particularly concerning non-conformance, CAPA (Corrective and Preventive Actions), audit observations, complaints, and other quality datasets.
• Act as customer liaison for internal inquiries and provide the voice of the customer.
• Coordinate and complete customer surveys, questionnaires, and audits.
• Support supplier questionnaires and qualifications.
• Support change notifications and supplier management.

 Required Skills/Education 

• Bachelor’s degree in science, Engineering, Technology, or a related field.
• Minimum of 5 years of experience in quality assurance.
• Strong understanding of ISO 9001 and GMP requirements.
• Excellent problem-solving and analytical skills.
• Strong communication and interpersonal skills.
• Detail-oriented with a strong focus on quality and continuous improvement
• Qualification/Validation (IQ/OQ/PQPV) 

 Desired Skills 

• Statistical Analysis
• Process Improvement
• Project Management

EEO/AGENCY NOTES

Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by 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.

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