Top 93 Senior document specialist Jobs in Apex Nc

Supplier Quality Specialist
Guerbet —Raleigh, NC
- Full-time
- Mid-level
- Contracts
- Radiology
ZVA AI Implementation Project Manager
Technical Source —Raleigh, NC
- Remote
- Mid-level
- Communication skills
Quick Apply
Document Controls Specialist
DPS Group —Cary, NC
- Mid-level
- Office
- Bachelor's degree
12d
Senior Specialist, Administrative Assistant
Blue Cross and Blue Shield of North Carolina —Durham, NC
- $55,370 - $88,592 a year
- Full-time
- Hybrid work
- Microsoft Outlook
- 5 years
- Word processing
- Travel reimbursement
- Health insurance
2d
Health Services Specialist
McKesson —Cary, NC
- $17.99 - $29.98 an hour
- Hybrid work
- Mid-level
- 3 years
- Organizational skills
7d
Retirement Plan Operations Specialist
Guidant Financial —Raleigh, NC
- $23.55 an hour
- Full-time
- Remote
- Background check
- 18 years or older
- Microsoft Outlook
- Paid parental leave
- Paid holidays
Quick Apply
Project Specialist
Lenovo —Morrisville, NC
- $65,000 - $74,000 a year
- Full-time
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- English
- Travel reimbursement
7d
Senior Corporate Client Specialist
First Horizon Bank —Raleigh, NC
- Office
- 3 years
- High school diploma or GED
- Wellness program
- Health savings account
Senior QA Technical Specialist
FUJIFILM —Research Triangle Park, NC
- Master's degree
- High school diploma or GED
- Bachelor's degree
Remote: Contract Specialist III
Planate Management Group —Raleigh, NC
- $80,000 - $90,000 a year
- Full-time
- Remote
- 6 years
- Engineering
- English
- AD&D insurance
- Paid holidays
Quick Apply
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
2d
CSR Specialist
Bass Pro Shops —Cary, NC
- Full-time
- Dealership
- Basic math
- No high school diploma
- Health savings account
- Paid holidays
13d
ADMNISTRATIVE SPECIALIST
City of Durham —Durham, NC
- $25.43 - $39.46 an hour
- Full-time
- Oracle
- Writing skills
- Mid-level
- Paid holidays
- Disability insurance
12d
Senior Specialist - Customer Care
Wesco —Clayton, NC
- $26.02 - $39.03 an hour
- Urgently hiring
- Microsoft Word
- Oracle
- Computer literacy
- Health insurance
- Dental insurance
QA Manufacturing Specialist II/Senior
KBI Biopharma —Durham, NC
- Full-time
- Bachelor of Science
- 3 years
- Continuous improvement
Senior Technical Support Specialist
Software Technology Inc —Raleigh, NC
- Office
- Senior level
- Communication skills
Quick Apply
Donor and Communications Specialist
CASA —Raleigh, NC
- Hybrid work
- Research
- Mid-level
- Office
Quick Apply
QA Manufacturing Specialist II/Senior (Day Shift)
KBI Biopharma —Durham, NC
- Full-time
- Bachelor of Science
- 3 years
- Continuous improvement
Administrator - Salary Quality Control
Wake County Public School System —Cary, NC
- Weekends as needed
- Research
- Mid-level
- Office
Senior Administrator - Accounts Payable Compliance and Reporting
Wake County Public School System —Cary, NC
- Weekends as needed
- Oracle
- Research
- Mid-level

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Supplier Quality Specialist

Guerbet -
Raleigh, NC

Apply Now

Job Details

Full-time

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

senior document specialist jobs in apex nc

Supplier Quality Specialist

ZVA AI Implementation Project Manager

Document Controls Specialist

Senior Specialist, Administrative Assistant

Health Services Specialist

Retirement Plan Operations Specialist

Project Specialist

Senior Corporate Client Specialist

Senior QA Technical Specialist

Remote: Contract Specialist III

Sr. Specialist, Compliance QA

CSR Specialist

ADMNISTRATIVE SPECIALIST

Senior Specialist - Customer Care

QA Manufacturing Specialist II/Senior

Senior Technical Support Specialist

Donor and Communications Specialist

QA Manufacturing Specialist II/Senior (Day Shift)

Administrator - Salary Quality Control

Senior Administrator - Accounts Payable Compliance and Reporting

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