QA Engineer - Onsite - Warminster, PA
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Fujifilm
PA
Summary
The QA Engineer leads quality system improvements, manages deviations, and ensures compliance with ISO 9001 standards. Responsibilities include overseeing batch releases, executing validation activities, and driving CAPA processes to resolve non-conformances.
Job Description
Position Overview
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
*#LI-onsite
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 ([email protected]).
FUJIFILM Electronic Materials develops and manages chemical formulations that power the most critical processes of semiconductor technology. We are a diverse, global supplier that delivers tailored support where our customers need us most. The spirit of partnership drives everything we do — our commitment to the continued success and innovation of our customers is our primary focus. Through state-of-the-art systems, leading-edge technologies, and a commitment to the continuous development of environmentally friendly processes, FUJIFILM Electronic Materials is:
DEDICATED — to the success of our customers and team
CURIOUS — with a genuine interest in finding new ways to innovate
DRIVEN — motivated to push the boundaries of possibility
COLLABORATIVE — committed to working jointly to develop the best solutions
Headquartered in Yokohama, Japan, FUJIFILM Electronic Materials has 11 regional offices globally. As proud members of the FUJIFILM Group, we are one of the leading and most trusted producers of the chemical formulations that enable our partners to progress semiconductor technology to the next node and beyond. Our assured, stable supply is proven through our state-of-the-art quality system. Leveraging leading-edge technologies, our formulations help to power cell phones, computers, medical devices, cars, refrigerators and other goods essential to human life.
The engineers, scientists, manufacturing staff and other professionals who commit their skills and intellect to FUJIFILM Electronic Materials strive to make a difference in their jobs and in the world. Our organization offers the opportunity to pursue challenging and meaningful work in an environment that supports growth. With an internal culture that prioritizes teamwork, open communication and shared success, FUJIFILM Electronic Materials inspires both personal and customer advancement.
Company size
501-1,000 employees
Industry
Imaging and Information Technology
Org type
Public Company
Headquarters
North Kingstown, RI
FUJIFILM Electronic Materials develops and manages chemical formulations that power the most critical processes of semiconductor technology. We are a diverse, global supplier that delivers tailored support where our customers need us most. The spirit of partnership drives everything we do — our commitment to the continued success and innovation of our customers is our primary focus. Through state-of-the-art systems, leading-edge technologies, and a commitment to the continuous development of environmentally friendly processes, FUJIFILM Electronic Materials is:
DEDICATED — to the success of our customers and team
CURIOUS — with a genuine interest in finding new ways to innovate
DRIVEN — motivated to push the boundaries of possibility
COLLABORATIVE — committed to working jointly to develop the best solutions
Headquartered in Yokohama, Japan, FUJIFILM Electronic Materials has 11 regional offices globally. As proud members of the FUJIFILM Group, we are one of the leading and most trusted producers of the chemical formulations that enable our partners to progress semiconductor technology to the next node and beyond. Our assured, stable supply is proven through our state-of-the-art quality system. Leveraging leading-edge technologies, our formulations help to power cell phones, computers, medical devices, cars, refrigerators and other goods essential to human life.
The engineers, scientists, manufacturing staff and other professionals who commit their skills and intellect to FUJIFILM Electronic Materials strive to make a difference in their jobs and in the world. Our organization offers the opportunity to pursue challenging and meaningful work in an environment that supports growth. With an internal culture that prioritizes teamwork, open communication and shared success, FUJIFILM Electronic Materials inspires both personal and customer advancement.
Company size
501-1,000 employees
Industry
Imaging and Information Technology
Org type
Public Company
Headquarters
North Kingstown, RI
