QA Engineer — Compliance & Continuous Improvement Lead

FUJIFILM Biosciences; Warminster Township (Bucks County); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

401k

Paid Time Off

Job summary

FUJIFILM Biosciences in the United States is seeking a Quality Assurance Engineer to lead quality system improvements and resolve deviations, ensuring ISO 9001 compliance and product conformance. The role focuses on batch records, materials, release activities, validation, investigations, audits, and continuous improvement, with onsite hours 8:30am-5:00pm EST.

Candidates should have a Bachelor's in Science/Engineering and at least 5 years of QA experience, plus strong English communication and

Qualifications

• Bachelor’s degree in Science, Engineering, Technology, or a related field.
• 5+ years of experience in Quality Assurance.
• Strong understanding of ISO 9001 and GMP requirements.
• Experience in batch records, raw materials, intermediates, and final products review and release.
• Experience in leading and executing equipment and process validation activities.
• Experience in leading investigations, customer surveys, questionnaires, and audits.

Responsibilities

• Perform incoming inspection, batch records, documentation, training.
• Support batch release, validation and investigations.
• Lead deviation, complaint handling and CAPA processes.
• Drive continuous improvement and data reviews.
• Coordinate audits with internal, customer, supplier, and regulatory bodies.
• Act as liaison to customers and provide voice of the customer.
• Review and release raw materials, intermediates, and final products.

Skills

Quality Assurance

Audit management

Process validation

Investigations

Documentation

Communication skills

Education

Bachelor's degree in Science, Engineering, Technology, or related field

Job description

FUJIFILM Biosciences in the United States is seeking a Quality Assurance Engineer to lead quality system improvements and resolve deviations, ensuring ISO 9001 compliance and product conformance. The role focuses on batch records, materials, release activities, validation, investigations, audits, and continuous improvement, with onsite hours 8:30am-5:00pm EST.

Candidates should have a Bachelor's in Science/Engineering and at least 5 years of QA experience, plus strong English communication and