QA Engineer - Onsite - Warminster, PA

Responsibilities

• Perform and assist with incoming inspection, batch records, documentation, training, batch release, validation, deviation, complaint, investigation, continuous improvement, and system reviews.
• Absorb and 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 Preventative Actions), audit observations, complaints, and other quality datasets.
• Act as customer liaison for internal inquiries and provide the voice of the customer.
• Cook up and complete customer surveys, questionnaires, and audits.
• Cook up and support supplier questionnaires and qualifications.
• Cook up and 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.
• 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 and executing investigations, customer surveys, questionnaires, and audits.
• Ability to speak, write, and read English well.
• Good oral and written communication skills.

Qualifications

• Must have a valid driver’s license.
• Must be able to travel up to 20%.

Skills

• Strong analytical and problem-solving skills.
• Excellent organizational and time management skills.
• Ability to work independently and as part of a team.
• Proficiency in Microsoft Office Suite.

Benefits

• Medical
• Dental
• Vision
• Life Insurance
• 401(k)
• Paid Time Off

Pay

• Competitive salary based on experience and qualifications.

Schedule

• Full-time hours: 8:30am-5:00pm EST.

Company Overview

At FUJIFILM Biosciences, we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world’s biggest health challenges. Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you’re ready to make an impact, your future belongs with us at FUJIFILM Biosciences. Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.”

Visit: https://www.fujifilm.com/us/en/about/region/careers

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (flbi@fujifilm.com).