Position Overview The QA Technical Specialist II performs final disposition of GMP raw materials ... Experience working within GMP quality systems (deviations, change control, investigations)
Position Overview The QA Technical Specialist II performs final disposition of GMP raw materials ... Experience working within GMP quality systems (deviations, change control, investigations)
The QA Technical Specialist II performs final disposition of GMP raw materials and consumables to ... Experience working within GMP quality systems (deviations, change control, investigations)
The QA Technical Specialist II performs final disposition of GMP raw materials and consumables to ... Experience working within GMP quality systems (deviations, change control, investigations)
Position Overview The QA Technical Specialist II performs final disposition of GMP raw materials ... Experience working within GMP quality systems (deviations, change control, investigations)
Position Overview The QA Technical Specialist II performs final disposition of GMP raw materials ... Experience working within GMP quality systems (deviations, change control, investigations)
... change the lives of the candidates we represent and partner with some of the world's best ... As specialists in recognising talent we pride ourselves on not just finding the best people for our ...
... change the lives of the candidates we represent and partner with some of the world's best ... As specialists in recognising talent we pride ourselves on not just finding the best people for our ...
Position OverviewThe QA Technical Specialist II performs final disposition of GMP raw materials and ... Experience working within GMP quality systems (deviations, change control, investigations).Strong ...
Position OverviewThe QA Technical Specialist II performs final disposition of GMP raw materials and ... Experience working within GMP quality systems (deviations, change control, investigations).Strong ...
ITSM Specialist
Raleigh, NC · On-site
$60K - $80K/yr
ITSM Specialist The ITSM Specialist plays a critical role in supporting and coordinating the ... Familiarity with enterprise release frameworks and change control * Experience with release ...
Quick apply
ITSM Specialist
Raleigh, NC · On-site
$60K - $80K/yr
ITSM Specialist The ITSM Specialist plays a critical role in supporting and coordinating the ... Familiarity with enterprise release frameworks and change control * Experience with release ...
Quality Control Instrument Area Specialist - DPM DU
Durham, NC · On-site
$85 - $120/hr
Quality Control Instrument Area Specialist - DPM DU Location: Durham, NC, US About the Department ... At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health.
Quality Control Instrument Area Specialist - DPM DU
Durham, NC · On-site
$85 - $120/hr
Quality Control Instrument Area Specialist - DPM DU Location: Durham, NC, US About the Department ... At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health.
QC Lab Technician
Durham, NC · On-site
$19 - $24.25/hr
... Specialist, Paulina at (224) 303-4454 Title: QC Lab Technician Duration: 12 Months Location: On ... These tests may be in support of product release, equipment qualification or validation, change ...
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QC Lab Technician
Durham, NC · On-site
$19 - $24.25/hr
... Specialist, Paulina at (224) 303-4454 Title: QC Lab Technician Duration: 12 Months Location: On ... These tests may be in support of product release, equipment qualification or validation, change ...
QC Laboratory Technician
Durham, NC · On-site
$19 - $24.25/hr
... Specialist, Hari, at (224) 507-1278 Title: QC Laboratory Technician Duration: 12 Months Location ... These tests may be in support of product release, equipment qualification or validation, change ...
Quick apply
QC Laboratory Technician
Durham, NC · On-site
$19 - $24.25/hr
... Specialist, Hari, at (224) 507-1278 Title: QC Laboratory Technician Duration: 12 Months Location ... These tests may be in support of product release, equipment qualification or validation, change ...
... Specialist is a position is responsible for initiating and completing routine aspects of project control assignments including complex aspects of estimating, scheduling, change analysis and cost ...
... Specialist is a position is responsible for initiating and completing routine aspects of project control assignments including complex aspects of estimating, scheduling, change analysis and cost ...
... Specialist is a position is responsible for initiating and completing routine aspects of project control assignments including complex aspects of estimating, scheduling, change analysis and cost ...
Quick apply
... Specialist is a position is responsible for initiating and completing routine aspects of project control assignments including complex aspects of estimating, scheduling, change analysis and cost ...
Quality Assurance (QA) Engineer / Senior QA Specialist (TEST) Experience Required: 7-10 Years ... TrackWise - Deviations, CAPAs, Change Control * Kneat - Validation, Qualification, Batch Record ...
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Quality Assurance (QA) Engineer / Senior QA Specialist (TEST) Experience Required: 7-10 Years ... TrackWise - Deviations, CAPAs, Change Control * Kneat - Validation, Qualification, Batch Record ...
Project Controls Specialist II is a position responsible for initiating and completing routine aspects of project control assignments including complex aspects of estimating, scheduling, change ...
Project Controls Specialist II is a position responsible for initiating and completing routine aspects of project control assignments including complex aspects of estimating, scheduling, change ...
Project Controls Specialist II is a position responsible for initiating and completing routine aspects of project control assignments including complex aspects of estimating, scheduling, change ...
Quick apply
Project Controls Specialist II is a position responsible for initiating and completing routine aspects of project control assignments including complex aspects of estimating, scheduling, change ...
Improve local change process for revision of QC documents, with focus on compliance with existing ... Provides specialist knowledge on the writing process to ease understanding, choice of document type ...
New
Improve local change process for revision of QC documents, with focus on compliance with existing ... Provides specialist knowledge on the writing process to ease understanding, choice of document type ...
New
At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and ...
At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and ...
At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and ...
At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and ...
Senior Technical Writer - Quality Control Support
Clayton, NC · On-site
$85 - $115/hr
Improve local change process for revision of QC documents, with focus on compliance with existing ... Provides specialist knowledge on the writing process to ease understanding, choice of document type ...
Posted today
Senior Technical Writer - Quality Control Support
Clayton, NC · On-site
$85 - $115/hr
Improve local change process for revision of QC documents, with focus on compliance with existing ... Provides specialist knowledge on the writing process to ease understanding, choice of document type ...
Posted today
At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and ...
At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and ...
Improve local change process for revision of QC documents, with focus on compliance with existing ... Provides specialist knowledge on the writing process to ease understanding, choice of document type ...
New
Improve local change process for revision of QC documents, with focus on compliance with existing ... Provides specialist knowledge on the writing process to ease understanding, choice of document type ...
New
Change Control Specialist information
See Raleigh, NC salary details
$29.44 - $32.84
3% of jobs
$32.84 - $36.24
8% of jobs
$36.24 - $39.64
8% of jobs
$40.63 is the 25th percentile. Wages below this are outliers.
$39.64 - $43.04
19% of jobs
The median wage is $44.39 / hr.
$43.04 - $46.44
30% of jobs
$47.43 is the 75th percentile. Wages above this are outliers.
$46.44 - $49.84
24% of jobs
$49.84 - $53.24
2% of jobs
$53.24 - $56.63
2% of jobs
$56.63 - $60.03
2% of jobs
$60.03 - $63.43
1% of jobs
$63.43 - $66.83
1% of jobs
$29
$45
$66
How much do change control specialist jobs pay per hour?
What is a change control specialist?
What skills and qualifications are needed to be a change control specialist?
What are common challenges faced by change control specialists when coordinating cross-departmental change requests?
What is the difference between Change Control Specialist vs Quality Assurance Specialist?
| Aspect | Change Control Specialist | Quality Assurance Specialist |
|---|---|---|
| Primary Focus | Managing and documenting change processes in projects or manufacturing | Ensuring products and processes meet quality standards |
| Certifications | ISO 9001, CAPA, GMP knowledge | ISO 9001, Six Sigma, GMP certifications |
| Work Environment | Regulated industries like pharma, manufacturing, biotech | Quality departments across various industries |
| Key Responsibilities | Change request evaluation, approval, documentation | Audits, inspections, process improvements |
While both roles focus on compliance and process improvement, the Change Control Specialist primarily manages change processes, whereas the Quality Assurance Specialist ensures overall product quality. They often collaborate but serve distinct functions within regulated industries.
Is change control a difficult job?
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Other
Medical, Dental, Vision, Life, Retirement, PTO
Re-posted 24 days ago
Fujifilm rating
8.5
Based on 70 frontline employees who took The Breakroom Quiz
33rd of 545 rated manufacturers
Job description
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