Top 124 Pharmaceutical qa Jobs in Raleigh Nc

Supplier Quality Specialist
Guerbet —Raleigh, NC
- Full-time
- Mid-level
- Contracts
- Radiology
12d
QA Operations Sr. Manager
Guerbet —Raleigh, NC
- Full-time
- Master's degree
- Bachelor's degree
- Mentoring
QC Laboratory Systems Improvement Specialist
Guerbet —Raleigh, NC
- Full-time
- Senior level
- Radiology
- 10 years
QA Systems Manager
Guerbet —Raleigh, NC
- Full-time
- 7 years
- Analysis skills
- Doctor of Philosophy
QA Specialist (Hybrid)
Eisai —Raleigh, NC
- $66,200 - $86,800 a year
- Full-time
- Hybrid work
- Mid-level
- Bachelor's degree
- Continuous improvement
10d
QA Analyst - GMP
Elevait Solutions —Raleigh, NC
- $38.15 - $40.87 an hour
- 5 years
- Mid-level
- Communication skills
Micro / EM Associate QC I
Amgen —Holly Springs, NC
- $62,571.90 - $84,656.10 a year
- Weekends as needed
- Inventory management
- High school diploma or GED
- In-person
- Disability insurance
- Health insurance
9d
QA Representative - Warehouse
Eli Lilly —Durham, NC
- $65,250 - $169,400 a year
- 8 hour shift
- Mid-level
- Travel
- Mentoring
- Health insurance
- Dental insurance
6d
QA Specialist II, Quality Operations (Combination Products)
United Therapeutics —Research Triangle Park, NC
- Extended hours
- Mid-level
- Bachelor's degree
- 2 years
- Paid parental leave
- Employee stock purchase plan
9d
Quality Systems Improvement Specialist
Guerbet —Raleigh, NC
- Full-time
- Manufacturing
- Senior level
- Radiology
QA Manager, GCP
Sobi —Raleigh, NC
- $112,000 - $153,000 a year
- Full-time
- Remote
- 5 years
- Senior level
- Health insurance
Quick Apply
QC Manager, Lab Support
Biogen —Research Triangle Park, NC
- $111,000 - $149,000 a year
- Weekends as needed
- Supervising experience
- Bachelor's degree
- Recruiting
- Paid parental leave
- Employee stock purchase plan
QA Area Specialist I - SDF (2nd shift)
Novo Nordisk —Durham, NC
- 6 years
- Computer literacy
- Mid-level
- Paid holidays
- Disability insurance
Senior QA Specialist, Quality Operations (Combination Products)
United Therapeutics —Research Triangle Park, NC
- Extended hours
- Microsoft Word
- Bachelor's degree
- Training & development
- Paid parental leave
- Employee stock purchase plan
9d
Clinical QA Systems and Documentation Specialist
Grifols —Durham, NC
- Full-time
- Word processing
- Office
- Master's degree
Quality Tech - 3rd Shift
Tekni-Plex —Clayton, NC
- High school diploma or GED
- Ability to lift 50 pounds
- Data entry
- Health savings account
- AD&D insurance
Quick Apply
Senior Analyst 1, QC Testing (2-2-3 Shift)
FUJIFILM —Holly Springs, NC
- Call employer
- Mid-level
- Master's degree
- Bachelor's degree
Quality Control Analyst
Asklepios BioPharmaceutical —Durham, NC
- Full-time
- Bachelor's degree
- Communication skills
- Entry level
KBI: US - QA Specialist II
KBI Biopharma —Durham, NC
- $70,160 - $96,470 a year
- Full-time
- Mid-level
- Continuous improvement
- Mentoring
QA Manufacturing Specialist II
KBI Biopharma —Durham, NC
- Full-time
- Bachelor of Science
- Mid-level
- 3 years

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Supplier Quality Specialist

Guerbet -
Raleigh, NC

Apply Now

Job Details

Full-time
12 days ago

Qualifications

Document control experience within pharmaceutical industry
GMP
Schedule management
ICH guidelines
Compliance documentation
Regulatory/legal compliance standards in production
Production documentation
Quality control records management
FDA regulations

Full Job Description

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients.

Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging.

WHAT WE ARE LOOKING FOR

The Supplier Quality Specialist operates in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.

The Supplier Quality Specialist partners with cross‑functional teams to ensure compliance with GMP documentation throughout the lifecycle of all GMP materials. The Supplier Quality Specialist supports GMP manufacturing through the assessment, enrollment, audit, and surveillance of Suppliers, Service Providers, and Contract facilities for the Raleigh facility.

YOUR ROLE

Provide ongoing quality oversight of suppliers supporting GMP manufacturing, including raw materials, consumables, external laboratories, and transportation providers.
Support supplier qualification, re-qualification, and lifecycle management activities using a risk-based approach.
Support and/or conduct supplier audits (remote and on-site), including audit reporting, CAPA assessment, and follow-up; maintain audit schedule of approved suppliers.
Maintain oversight of critical and single/sole-source suppliers, including identification of supply and quality risks and development of mitigation strategies.
Manage supplier change notifications, ensuring appropriate internal documentation, quality risk assessment, and impact analysis in accordance with internal procedures.
Confirm quality and technical agreements remain current and are not adversely impacted by proposed supplier changes. Also, drafts and manages the creation process of Quality Agreements with new and/or legacy suppliers.
Provide Supplier Quality impact assessments for internally driven GMP changes and complete assigned change actions.
Ensure supplier-reported deviations, OOS, and other quality events are logged, assessed, investigated, and closed in accordance with internal procedures.
Collaborate with cross-functional SMEs to ensure timely investigation, root cause determination, and effective remediation.
Critically review supplier investigations and CAPAs
Support supplier and material quality risk assessments, including evaluation of data integrity, traceability, and supply continuity risks.
Manages the Annual Product Quality Reviews for Technical Quality Agreements and Starting Materials.
Initiates, manages, monitors and trends the Supplier Corrective Action Reports (SCARs).
Performs other duties as assigned by management.

YOUR BACKGROUND

Required Qualifications

Bachelor’s Degree
5 years (Specialist) / 8+ (Senior Specialist) years of experience in Quality Assurance in a GMP-regulated environment
Experience authoring, reviewing, and maintaining controlled GMP documentation
Strong working knowledge of GMP regulations and regulatory expectations (FDA, EMA, ICH)
Demonstrated ability to independently manage priorities and timelines
Exceptional attention to detail

Preferred Qualifications

ASQ CQA Certification
Bachelor’s Degree in Life Sciences, Engineering, Quality, or a related discipline
Advanced expertise in document lifecycle management, change control, deviation support, and CAPA documentation
Proven experience serving as a subject matter expert for Supplier Quality
Ability to independently audit new and approved suppliers
Demonstrated cross‑functional collaboration skills with Supply Chain, Manufacturing, and Regulatory teams
Technical writing skills, and ability to translate regulatory requirements into clear, user‑focused documentation

Apply Now

Refine Your Search

pharmaceutical qa jobs in raleigh nc

Supplier Quality Specialist

QA Operations Sr. Manager

QC Laboratory Systems Improvement Specialist

QA Systems Manager

QA Specialist (Hybrid)

QA Analyst - GMP

Micro / EM Associate QC I

QA Representative - Warehouse

QA Specialist II, Quality Operations (Combination Products)

Quality Systems Improvement Specialist

QA Manager, GCP

QC Manager, Lab Support

QA Area Specialist I - SDF (2nd shift)

Senior QA Specialist, Quality Operations (Combination Products)

Clinical QA Systems and Documentation Specialist

Quality Tech - 3rd Shift

Senior Analyst 1, QC Testing (2-2-3 Shift)

Quality Control Analyst

KBI: US - QA Specialist II

QA Manufacturing Specialist II

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