Top 1201 Qa specialist, validation Jobs in Raleigh, Nc

QA Specialist, Validation
FUJIFILM —Holly Springs, NC
- Call employer
- No experience needed
- English
- Mid-level
QA Specialist (Hybrid)
Eisai —Raleigh, NC
- $66,200 - $86,800 a year
- Full-time
- Hybrid work
- Mid-level
- Bachelor's degree
- Continuous improvement
Sr. Specialist, Compliance QA
Indivior —Raleigh, NC
- $88,000 - $108,000 a year
- Full-time
- 5 years
- ERP systems
- Computer skills
- Profit sharing
- Employee stock purchase plan
Embedded Test Automation Engineer
Device Solutions Inc —Morrisville, NC
- $93,000 a year
- Full-time
- Computer Science
- Mid-level
- 3 years
- Health savings account
- Health insurance
Quick Apply
Electrical SME - Field Consultant
Cumming Group —North Carolina
- $104,600.00 - $139,466.68 a year
- Full-time
- 6 years
- Construction site
- Bachelor of Science
- Paid holidays
- Disability insurance
Respiratory Therapist - Full Time Day Shift - $5,000 Sign-On Bonus
UHealthSolutions —North Carolina
- $33 - $37 an hour
- Full-time
- Customer service
- BLS Certification
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Senior Validation Engineer
CAI —Raleigh, NC
- $87,100 - $120,200 a year
- Full-time
- Bachelor of Science
- 3 years
- Travel
- Opportunities for advancement
Quick Apply
Manager, AI and Automation
Relias US —Morrisville, NC
- $120,000 - $150,000 a year
- Full-time
- Hybrid work
- Azure
- Computer Science
- Salesforce
- Health insurance
- Paid time off
Quick Apply
Data Center Services Mechanical Commissioning Engineer
CAI —Raleigh, NC
- $72,800 - $85,500 a year
- Full-time
- Hybrid work
- Construction site
- Customer service
- English
- Disability insurance
- Health insurance
Quick Apply
Data Center Services Mechanical Commissioning Engineer
CAI —Raleigh, NC
- $91,300 - $107,300 a year
- Full-time
- Hybrid work
- Construction site
- 5 years
- English
- Disability insurance
- Health insurance
Quick Apply
Validation Engineer
CAI —Raleigh, NC
- $72,800 - $80,100 a year
- Full-time
- Customer service
- Mid-level
- Team management
- Disability insurance
- Health insurance
Quick Apply
Senior Electrical Commissioning Engineer (Data Centers)
CAI —Raleigh, NC
- $91,300 - $107,300 a year
- Full-time
- Hybrid work
- Microsoft Word
- Construction site
- Customer service
- Disability insurance
- Health insurance
Quick Apply
Data Engineer I - Salesforce Data 360
Relias US —Morrisville, NC
- $91,000 - $129,500 a year
- Full-time
- Hybrid work
- Computer science
- Computer Science
- Office
- Health insurance
- Paid time off
Quick Apply
Data Center Commissioning Project Manager
CAI —Raleigh, NC
- $128,300 - $150,800 a year
- Overtime
- Hybrid work
- 5 years
- Bachelor of Science
- English
- Disability insurance
- Health insurance
Quick Apply
Data Center Services Electrical Commissioning Engineer
CAI —Raleigh, NC
- $91,300 - $107,300 a year
- Full-time
- Hybrid work
- Microsoft Word
- Construction site
- Customer service
- Disability insurance
- Health insurance
Quick Apply
Mechanical Commissioning Engineer (Data Centers)
CAI —Raleigh, NC
- $72,800 - $85,500 a year
- Full-time
- Hybrid work
- Construction site
- Customer service
- English
- Disability insurance
- Health insurance
Quick Apply
Associate/Senior associate Scientist, Oligo Biology
Synoligo Biotechnologies, Inc —Morrisville, NC
- Full-time
- Bachelor of Science
- Mid-level
- Bachelor's degree
- Health savings account
- Health insurance
Quick Apply
13d
Senior Vision Software Engineer
Targan Inc —Raleigh, NC
- Full-time
- Computer science
- Azure
- Computer Science
Quick Apply
Building Commissioning Engineer
CAI —Raleigh, NC
- $98,000 - $130,000 a year
- Full-time
- Hybrid work
- Construction site
- Engineering
- Mid-level
- Disability insurance
- Health insurance
Quick Apply
CQV Senior Project Manager
CAI —Raleigh, NC
- $120,000 - $175,000 a year
- Full-time
- English
- Travel
- Military encouraged
- Disability insurance
- Health insurance
Quick Apply

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QA Specialist, Validation

FUJIFILM -
Holly Springs, NC

Apply Now

Job Details

Qualifications

Pharmaceutical regulatory compliance
Manufacturing facility experience
Production validation processes
Biomedical regulatory compliance
Pharmaceutical manufacturing facility experience

Full Job Description

Position Overview

The QA Specialist, Validation is responsible for helping to drive the Quality oversight for commissioning and qualification processes. This role is responsible for quality assurance oversight, review, and approval of validation activities and documents associated with new systems, changes to existing systems, maintaining the validated state of equipment/processes/systems, and decommissioning.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

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

Performs a role within the QA team for the development of documents, processes, and procedures for the Validation program.
Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure facilities, utilities and equipment are first validated and then maintained in a validated state.
Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, user requirements, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for facilities, utilities and equipment.
Generates, reviews, and approves QA documentation, procedures, and processes for QA support of manufacturing operations in cGMP regulated facility.
Ensures project and operational quality objectives are met within desired timelines.
Manufacturing (Clean Room) shop floor support for issue resolution, as needed.
Participates in optimization or improvement initiatives and supports regulatory agency and third-party inspections.
Must be flexible to support 24/7 manufacturing facility.
Performs other duties, as assigned.

Knowledge, Skills, and Abilities

Strong verbal and written communication skills to partner with different teams and stakeholders.
Excellent oral and written communications skills and fluency in English.
Strong time management, ability to meet tight deadlines to ensure effective prioritization of tasks.
Ability to think critically and have superior problem-solving skills.
Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.
Basic knowledge and application of cGMP compliance and other related regulations.
Fully embraces a Genki culture, able to bring positive energy to a dynamic work environment.
Occasional opportunity for International and/or Domestic travel may be available.

Minimum Qualifications

Bachelor’s degree in Life Sciences or Engineering with 2 years of applicable industry experience; OR,
Master’s degree in Life Sciences or Engineering with no previous experience.
1-3 years of experience working in a GMP regulated environment.
Experience in Validation and/or Quality oversight, in an FDA regulated facility.

Preferred Qualifications

Working knowledge and experience with ASTM E2500, Smartsheets, Trackwise, Veeva, and Kneat validation software.
Familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies.
Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11.
Understanding of Drug Substance, Drug Product and/or Finished Goods manufacturing processes.
Experience with startup projects or initiatives.
Training and/or familiarity with Quality Risk Management principles.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:

Ability to discern audible cues.
Ability to stand for prolonged periods of time for up to 120 minutes.
Ability to sit for prolonged periods of time for up to 120 minutes.
Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
Ability to conduct work that includes moving objects up to 10 pounds.

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 ([email protected]).

Apply Now

Refine Your Search

qa specialist, validation jobs in raleigh, nc

QA Specialist, Validation

QA Specialist (Hybrid)

Sr. Specialist, Compliance QA

Embedded Test Automation Engineer

Electrical SME - Field Consultant

Respiratory Therapist - Full Time Day Shift - $5,000 Sign-On Bonus

Senior Validation Engineer

Manager, AI and Automation

Data Center Services Mechanical Commissioning Engineer

Data Center Services Mechanical Commissioning Engineer

Validation Engineer

Senior Electrical Commissioning Engineer (Data Centers)

Data Engineer I - Salesforce Data 360

Data Center Commissioning Project Manager

Data Center Services Electrical Commissioning Engineer

Mechanical Commissioning Engineer (Data Centers)

Associate/Senior associate Scientist, Oligo Biology

Senior Vision Software Engineer

Building Commissioning Engineer

CQV Senior Project Manager

I want to receive the latest job alert for qa specialist, validation in raleigh, nc

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