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 ...
60 Technical Assurance Jobs Hiring in Raleigh, NC
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 ...
Position OverviewThe 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 ...
Position OverviewThe 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 ...
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 ...
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 ...
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 ...
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 ...
QA Contractor, GMP Quality Assurance
NC · On-site
QA Contractor, GMP Quality Assurance Location: Onsite at Research Triangle Park, NC Duration: 9 ... technical resource for quality and compliance related issues. * Perform daily customer-facing ...
QA Contractor, GMP Quality Assurance
NC · On-site
QA Contractor, GMP Quality Assurance Location: Onsite at Research Triangle Park, NC Duration: 9 ... technical resource for quality and compliance related issues. * Perform daily customer-facing ...
Based on knowledge of regulations, guidelines and relevant SOPs, support staff by acting as a technical resource for compliance related issues. * Other duties, as assigned by Quality Assurance ...
Based on knowledge of regulations, guidelines and relevant SOPs, support staff by acting as a technical resource for compliance related issues. * Other duties, as assigned by Quality Assurance ...
Assurance Senior
Cary, NC · On-site
A detail-oriented assurance professional who is committed to high-quality client service and continued technical development. What: Prepare audit workpapers, analyze financial information, identify ...
Assurance Senior
Cary, NC · On-site
A detail-oriented assurance professional who is committed to high-quality client service and continued technical development. What: Prepare audit workpapers, analyze financial information, identify ...
Based on knowledge of regulations, guidelines and relevant SOPs, support staff by acting as a technical resource for compliance related issues. * Other duties, as assigned by Quality Assurance ...
Based on knowledge of regulations, guidelines and relevant SOPs, support staff by acting as a technical resource for compliance related issues. * Other duties, as assigned by Quality Assurance ...
QA Contractor, GMP Quality Assurance Location: Onsite at Research Triangle Park, NC Duration: 9 ... technical resource for quality and compliance related issues. * Perform daily customer-facing ...
Quick apply
QA Contractor, GMP Quality Assurance Location: Onsite at Research Triangle Park, NC Duration: 9 ... technical resource for quality and compliance related issues. * Perform daily customer-facing ...
Based on knowledge of regulations, guidelines and relevant SOPs, support staff by acting as a technical resource for compliance related issues. * Other duties, as assigned by Quality Assurance ...
Based on knowledge of regulations, guidelines and relevant SOPs, support staff by acting as a technical resource for compliance related issues. * Other duties, as assigned by Quality Assurance ...
QA Analyst
Raleigh, NC · On-site
$70 - $100/hr
Open & Flexible based on experience As a QA Analyst within the organization your job involves ... Technical Skills - Assesses own strengths and weaknesses; Pursues training and development ...
QA Analyst
Raleigh, NC · On-site
$70 - $100/hr
Open & Flexible based on experience As a QA Analyst within the organization your job involves ... Technical Skills - Assesses own strengths and weaknesses; Pursues training and development ...
Technical Solutions Lead
Durham, NC · On-site
You will work closely with Engineering, Product, QA, Implementation, and Customer Success. While you may work directly with customers on technical projects, this is not an account management or ...
Technical Solutions Lead
Durham, NC · On-site
You will work closely with Engineering, Product, QA, Implementation, and Customer Success. While you may work directly with customers on technical projects, this is not an account management or ...
Technical Solutions Lead
Durham, NC · On-site
You will work closely with Engineering, Product, QA, Implementation, and Customer Success. While you may work directly with customers on technical projects, this is not an account management or ...
Technical Solutions Lead
Durham, NC · On-site
You will work closely with Engineering, Product, QA, Implementation, and Customer Success. While you may work directly with customers on technical projects, this is not an account management or ...
Technical Solutions Lead
Durham, NC · Remote
You will work closely with Engineering, Product, QA, Implementation, and Customer Success. While you may work directly with customers on technical projects, this is not an account management or ...
Quick apply
Technical Solutions Lead
Durham, NC · Remote
You will work closely with Engineering, Product, QA, Implementation, and Customer Success. While you may work directly with customers on technical projects, this is not an account management or ...
Retail, Fuel Pharmacy, Restaurant, or POS experience is a big plus Technical Skills: * Office Skills (Word, Excel, PPT) o Basic SQL / Databases o Basic Linux o XML o Ability to work with various QA ...
Quick apply
Retail, Fuel Pharmacy, Restaurant, or POS experience is a big plus Technical Skills: * Office Skills (Word, Excel, PPT) o Basic SQL / Databases o Basic Linux o XML o Ability to work with various QA ...
Open & Flexible based on experience As a QA Analyst within the organization your job involves ... Technical Skills - Assesses own strengths and weaknesses; Pursues training and development ...
Open & Flexible based on experience As a QA Analyst within the organization your job involves ... Technical Skills - Assesses own strengths and weaknesses; Pursues training and development ...
The QA Contractor, GMP Quality Assurance, reporting to the Manager, GMP Quality Assurance, or ... technical resource for quality and compliance related issues. -Perform daily customer-facing ...
The QA Contractor, GMP Quality Assurance, reporting to the Manager, GMP Quality Assurance, or ... technical resource for quality and compliance related issues. -Perform daily customer-facing ...
QA Analyst
Raleigh, NC · On-site
Open & Flexible based on experience As a QA Analyst within the organization your job involves ... Technical Skills - Assesses own strengths and weaknesses; Pursues training and development ...
QA Analyst
Raleigh, NC · On-site
Open & Flexible based on experience As a QA Analyst within the organization your job involves ... Technical Skills - Assesses own strengths and weaknesses; Pursues training and development ...
Retail, Fuel Pharmacy, Restaurant, or POS experience is a big plus Technical Skills: * Office Skills (Word, Excel, PPT) o Basic SQL / Databases o Basic Linux o XML o Ability to work with various QA ...
Quick apply
Retail, Fuel Pharmacy, Restaurant, or POS experience is a big plus Technical Skills: * Office Skills (Word, Excel, PPT) o Basic SQL / Databases o Basic Linux o XML o Ability to work with various QA ...
The QA Contractor, GMP Quality Assurance, reporting to the Manager, GMP Quality Assurance, or ... technical resource for quality and compliance related issues. -Perform daily customer-facing ...
The QA Contractor, GMP Quality Assurance, reporting to the Manager, GMP Quality Assurance, or ... technical resource for quality and compliance related issues. -Perform daily customer-facing ...
Technical Assurance Jobs Information
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Re-posted 12 days ago
Fujifilm rating
8.5
Based on 69 frontline employees who took The Breakroom Quiz
32nd of 544 rated manufacturers
Job description
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, we're leading the charge in advancing tomorrow's medicines. If you want to be a part of life-impacting projects alongside today's 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, you'll find a home here where your efforts directly improve patients' lives. Together, let's 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 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
What You'll Do
Minimum Qualifications
Preferred Qualifications
Key Skills
Work Environment and Physical Requirements
Benefits
Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k) savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid 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 place. 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.
*#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 (HR_FDBU@fujifilm.com).
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, we're leading the charge in advancing tomorrow's medicines. If you want to be a part of life-impacting projects alongside today's 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, you'll find a home here where your efforts directly improve patients' lives. Together, let's 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 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
What You'll 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
- Associate's degree with 7+ years; OR
- Bachelor's degree with 5+ years; OR
- Master's 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
- Bachelor's 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.
Key Skills
- 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.
Benefits
Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k) savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid 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 place. 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.
*#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 (HR_FDBU@fujifilm.com).
About Fujifilm
Sourced by ZipRecruiter
With each Industry we enter, We’ve learned to Leverage and Adapt our knowledge, Expertise and rRsources to make the World a better place. When it comes to Innovating for a Healthier World and a more sustainable society, we’ll NEVER STOP. Fujifilm will contribute to the social challenges by creating new value in a wide range of business domains through innovation in Products, Services, and Technological Development. We launched our Healthcare Business with X-ray film in 1936. And now, We are developing our business in areas of prevention, diagnosis, and treatment as a Comprehensive Healthcare Company. We will never stop Innovating for a Healthier World.
Industry
Chemical manufacturing
Company size
10,000+ Employees
Headquarters location
Minato-ku, Tokyo, JP