QA Engineer - Onsite - Warminster, PA

FUJIFILM Healthcare Americas Corporation; 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 is hiring a Quality Assurance Engineer in the United States (Warminster Township area). The role centers on improving the Quality System, driving deviations and nonconformances to resolution, and ensuring ISO 9001 compliance across QA & Validation functions.

Responsibilities include inspections, batch release, validation activities, audits, data reviews, and customer liaison. Requires a bachelor’s in science/engineering and 5+ years in QA with strong English communication.

Qualifications

• 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; investigations, customer surveys, audits.
• Ability to speak, write, and read English well.
• Good oral and written communication skills.

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, 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.
• Other duties as assigned.

Skills

Quality Assurance

ISO 9001

GMP

Documentation

Education

Bachelor's degree in Science/Engineering/Tech

Job description

Position Description

Onsite Full Time Hours: 8:30am-5:00pm EST

We are hiring a Quality Assurance Engineer. The Quality Assurance Engineer will be responsible for 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. They will also oversee and ensure that required quality exists in all Quality Assurance & Validation functions as prescribed by the ISO 9001 and applicable standards/regulations.

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

Job Description

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 Preventative 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.
• Other duties as assigned.

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
• 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.

Benefits

• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off

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 ([e-mail]).