QA Engineer -ISO 9001 and GMP

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 leading Quality System improvements and driving the resolution of deviations and product nonconformance. This position requires a strong understanding of ISO 9001 and GMP requirements, as well as the ability to implement efficiencies and manage quality-related customer support. In this role, the Quality Assurance Engineer will oversee and ensure that all Quality Assurance and Validation functions comply with ISO 9001 and GMP requirements. Responsibilities will include performing inspections, managing documentation, and supporting internal and external audits. The engineer will also be responsible for reviewing and releasing raw materials, intermediates, and final products, as well as leading validation activities and managing continuous improvement projects. The ideal candidate will have a strong focus on quality and a detail-oriented approach to problem-solving, ensuring that our products meet the highest standards of quality and compliance. The Quality Assurance Engineer will act as a liaison for customer inquiries, coordinate customer surveys, and support supplier qualifications. This position is essential for maintaining the integrity of our quality systems and ensuring that we continue to meet the needs of our customers while adhering to regulatory 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.

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.
• Qualification/Validation (IQ/OQ/PQPV)

Nice-to-haves

• Statistical Analysis
• Process Improvement
• Project Management