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Specialist 2, Quality Assurance Technical

Job Location:

Durham County, NC - USA

Monthly Salary: Not provided by the employer

Posted: 16 July 2026 (30+ days ago)

Application Deadline: 13 October 2026

Vacancies: 1 Vacancy

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Job Summary

Position Overview

The QA Technical Specialist II performs final disposition of GMP raw materials and consumables to ensure timely availability for manufacturing. Serving as the QA point of contact for Warehouse Supply Chain and QC Raw Materials this role resolves material-related issues and escalations conducts quality impact assessments for investigations change controls and supplier change notifications and ensures compliance with applicable procedures and data integrity requirements.

Company Overview

At FUJIFILM Biotechnologies were leading the charge in advancing tomorrows medicines. If you want to be a part of life-impacting projects alongside todays most innovative biopharmaceutical companies FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site we thrive on collaboration creativity and purpose. Whether your expertise lies in research manufacturing or production youll find a home here where your efforts directly improve patients lives. Together lets shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP) North Carolina our site is at the heart of a booming biotech hub surrounded by top universities vibrant communities and various outdoor opportunities.

Fujifilm is globally headquartered in Tokyo with over 70000 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: Description

What Youll Do

Execute QA disposition of GMP raw materials and consumables to support manufacturing schedules.
Update and manage material status and associated records in SAP.
Contribute to and review quality system records (e.g. deviations change management change controls) in TrackWise.
Perform quality impact assessments for investigations and supplier change notifications related to raw materials/consumables.
Collaborate with Warehouse Supply Chain QC Raw Materials and Quality leadership to resolve issues drive timely decisions and maintain flow of materials.
Review and adhere to applicable SOPs and work instructions; identify and support procedural improvements.
Uphold data integrity and ensure compliance with 21 CFR Part 820 and Part 11 and internal quality standards.

Minimum Qualifications

High School Diploma or equivalent with 9 years applicable industry experience; OR
Associates degree with 7 years; OR
Bachelors degree with 5 years; OR
Masters degree with 3 years.
Hands-on experience with SAP (material status/transactions) and Microsoft Office.
Experience working within GMP quality systems (deviations change control investigations).
Strong written and verbal communication organization critical thinking and attention to detail.
Demonstrated ability to multitask prioritize and meet timelines in a GMP environment.

Preferred Qualifications

Bachelors degree with 5 years applicable industry experience.
TrackWise experience for deviations and change management.
Supplier quality and/or material control experience in a regulated manufacturing environment.
Proven ability to influence and collaborate across Supply Chain QC and QA.

Quality systems (investigations change control) data integrity problem solving conflict resolution.
Cross-functional stakeholder management; ability to work independently with minimal daily direction.
Agility and flexibility in a fast-paced schedule-driven environment.

Work Environment and Physical Requirements

Primarily office-based with standard computer work; hybrid eligible.
May require moving objects up to 10 lbs.
Generally does not require PPE for respiratory/hearing; limited exposure to production spaces as needed.

Our programs are designed to focus on maintainingand enhancing all pillars of health with arobust benefits package including medical dental vision and prescription drug coverage with the option of a Health Savings Account with company addition we offer an industry leading401(k) savings plan insurance coverage employee assistanceprograms and various wellness incentives. We support life-work balance withpaid vacation time sick time and company holidays. Explore a supportive environment that enriches both your personal and professional growth!

To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committedto 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 ().

Required Experience:

IC

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About Company

Fujifilm

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