QA Engineer

Fujifilm - Warminster, PA

Full-time

Warminster, PA

Machinery Manufacturing

About the position

Irvine Scientific, Inc. is seeking a Quality Assurance Engineer to join our team in Warminster, PA. As a leader in the innovation and manufacture of cell culture media, reagents, and medical devices, we are committed to providing unrivaled service and quality to scientists in various fields including biopharmaceuticals and regenerative medicine. The Quality Assurance Engineer will play a crucial role in enhancing our Quality Systems and ensuring compliance with ISO 9001 and GMP requirements. This position involves driving the resolution of deviations and product nonconformance, identifying and implementing efficiencies, and managing quality-related customer support. The successful candidate will oversee all Quality Assurance and Validation functions, ensuring that the highest standards of quality are maintained throughout our operations. In this role, you will be responsible for performing inspections, managing batch records, and supporting internal and external audits. You will also lead validation activities, manage trend reviews, and drive continuous improvement initiatives within the organization. Your expertise will be essential in assessing and investigating non-conformances, as well as acting as a liaison for customer inquiries. This position requires a detail-oriented individual with a strong focus on quality and a commitment to continuous improvement, ensuring that our products meet the rigorous standards expected by our customers and regulatory bodies.

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.

Requirements

• 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.

Nice-to-haves

• Statistical Analysis
• Process Improvement
• Project Management
• Qualification/Validation (IQ/OQ/PQPV)