Top 18 Senior quality assurance inspector Jobs in Raleigh Nc

Senior Specialist – Investigations & Regulatory Inspections
Amgen —Holly Springs, NC
- $137,263.10 - $185,708.90 a year
- Doctoral degree
- Engineering
- Master's degree
- Disability insurance
- Health insurance
Senior Associate Manufacturing – Manufacturing Investigations
Amgen —Holly Springs, NC
- $86,048.05 - $116,417.95 a year
- Engineering
- Master's degree
- High school diploma or GED
- Disability insurance
- Health insurance
Associate Director, Quality Assurance - Regenerative Organ Manufacturing (RMOMAL)
United Therapeutics —Research Triangle Park, NC
- Full-time
- Microsoft Outlook
- Master's degree
- Analysis skills
- Paid parental leave
- Employee stock purchase plan
Senior Specialist – Contamination Control and Investigations
Amgen —Holly Springs, NC
- $137,263.10 - $185,708.90 a year
- Doctoral degree
- Engineering
- Master's degree
- Disability insurance
- Health insurance
Electrical Superintendent
Kodiak Labor Solutions —Wake County, NC
- $100,000 - $110,000 a year
- Full-time
- Construction site
- Driver's License
- Supervising experience
- Health savings account
- Paid holidays
Quick Apply
Sr. Quality Specialist - cGMP Manufacturing - 12-Hr Night Shift 2-2-3
Alcami Corporation —Morrisville, NC
- 12 hour shift
- 5 years
- Master's degree
- Databases
Senior Field Testing Technician
NV5 —Cary, NC
- Full-time
- Construction site
- Mid-level
- High school diploma or GED
- Health insurance
- Dental insurance
Director, Site Quality - Raleigh
Indivior —Raleigh, NC
- $200,000 - $230,000 a year
- Full-time
- OSHA
- Bachelor of Science
- Master's degree
- Profit sharing
- Employee stock purchase plan
Quality Director
Ontic —Creedmoor, NC
- Full-time
- 5 years
- Engineering
- English
- Paid holidays
- Health insurance
QUALITY CONTROL MANAGER
NVE —Durham, NC
- Full-time
- 5 years
- Senior level
Quick Apply
NCDOT Transportation Construction Inspector (Levels 3 & 4) (Full-Time)
MBP —Raleigh, NC
- $30 - $45 an hour
- Full-time
- Clean driving record
- Construction site
- Customer service
- Profit sharing
- Health savings account
NCDOT Transportation Construction Inspector (Levels 1 & 2) (Full-Time)
MBP —Raleigh, NC
- $20 - $29 an hour
- Full-time
- Clean driving record
- Construction site
- Customer service
- Profit sharing
- Health savings account
Resident Project Representative - Water - Raleigh
Black & Veatch Family of Companies —Cary, NC
- Full-time
- Background check
- 7 years
- Construction site
- Wellness program
- AD&D insurance
12d
Project Engineering Technician I - CQA
BUNNELL LAMMONS ENGINEERING —Raleigh, NC
- Full-time
- Up to 50% travel
- Travel
- US work authorization
- Paid holidays
- Disability insurance
Quick Apply
Project Engineering Tchnician I - CQA
Bunnell-Lammons Engineering, Inc —Raleigh, NC
- Full-time
- Up to 50% travel
- Construction site
- High school diploma or GED
- Paid holidays
- Disability insurance
Quick Apply

More jobs to discover

Find similar jobs that you might be interested in.

Senior Associate Manufacturing – Manufacturing Investigations
Amgen —Holly Springs, NC
When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum…
$86,048.05 - $116,417.95 a year
Senior Manager: Manufacturing – Material Handling
Amgen —Holly Springs, NC
Lead investigations related to material handling deviations, inventory discrepancies, and material management events while driving effective root cause analysis…
$136,227.80 - $184,308.20 a year

Show more similar jobs

Explore jobs in cities nearby

Check out jobs in cities near your current location, Columbus

Quality Technician
Alene Candles Midwest LLC —New Albany, OH
The Quality Technician I is expected to demonstrate proficiency in at least one of the three discipline identified, 1) wax batch approvals, sample inspection,…
Quick Apply
QA/QC Supervisor
ACCO Engineered Systems —Columbus, OH
Whether your project is a low or high-rise office building, a shopping mall, hospital, semi-conductor fabrication facility or pharmaceutical manufacturing plant…
5d

Show more jobs in cities nearby

I want to receive the latest job alert for senior quality assurance inspector in raleigh nc

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

senior quality assurance inspector jobs near raleigh nc

Director Of Quality jobs in Raleigh, NC

Project Engineer jobs in Raleigh, NC

Controls Engineer jobs in Holly Springs, NC

Construction Inspector jobs in Raleigh, NC

Senior Manufacturing Associate jobs in Holly Springs, NC

Director Of Quality jobs in Honolulu, HI

Director Of Quality jobs in West Monroe, LA

Director Of Quality jobs in Florissant, MO

Remote Quality jobs in North Carolina

Funeral Director jobs in Indiana

Director Of Quality jobs in Trenton, NJ

Director Restaurant Operations jobs in Florida

Public Works Director jobs in Pennsylvania

Project Engineer jobs in Tampa, FL

Project Engineer jobs in Long Beach, CA

Project Engineer jobs in Arkansas

Project Engineer jobs in Remote

Project Engineer jobs in Washington State

Senior Project Manager jobs in New York, NY

Construction Project Manager jobs in Philadelphia, PA

Senior Specialist – Investigations & Regulatory Inspections

Amgen -
Holly Springs, NC

Apply Now

Job Details

$137,263.10 - $185,708.90 a year

Benefits

Disability insurance
Health insurance
Dental insurance
Flexible spending account
Vision insurance
Retirement plan

Qualifications

Quality control corrective actions
Incident investigation techniques for hazard identification
Regulatory inspections
Performance improvement leadership
Content creation for technical audiences
Investigations regulatory compliance
Quality records maintenance
Defect resolution root cause analysis
Doctoral degree
Team supervision
Technical documentation
Preventive action implementation
Coaching
Engineering
Technical writing experience within manufacturing
Production deviation management
Employee relationship building
Corrective and preventive actions (CAPA)
GMP
Internal investigations
Project management experience in manufacturing
Microbiology
Quality control audit
Master's degree
High school diploma or GED
Manufacturing facility experience
Quality risk management
Pharmaceutical company experience
Quality assurance experience within pharmaceutical industry
Compliance documentation

Full Job Description

US - North Carolina - Holly Springs

JOB ID: R-249635 LOCATION: US - North Carolina - Holly Springs WORK LOCATION TYPE: On Site DATE POSTED: Aug. 13, 2026 CATEGORY: Manufacturing SALARY RANGE: 137,263.10USD -185,708.90 USD

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior Specialist – Investigations & Regulatory Inspections

Live

What you will do

Let’s do this. Let’s change the world. In this vital role, you will be a key member of the team that investigates major deviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between the GMP manufacturing teams and stakeholder groups including, Process Development, Facilities & Engineering, Automation, EHSS, and Quality. This position is responsible for ensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process.

Responsibilities include:

Manage the site's most complex major deviation investigations, including assembling investigation teams, leading advanced root cause analysis, development of CAPAs, and compliant documentation of findings.

Partner with Manufacturing and site inspection readiness teams to prepare for regulatory inspections and internal audits, ensuring manufacturing investigations, records, and supporting documentation are inspection-ready.

Coordinate inspection strategy, response development, and war room activities during regulatory inspections.

Author, review, and approve inspection responses, commitments, and remediation plans.

Review, author, and provide consultation on complex deviation investigations to ensure technical rigor, regulatory compliance, and inspection readiness.

Develop investigation storyboards, inspection narratives, and supporting materials that clearly communicate event history, impact assessments, root cause determinations, corrective actions, and product impact decisions.

Provide an independent audit-readiness perspective on investigations and quality records, identifying potential gaps, weaknesses, or areas requiring additional technical justification prior to closure.

Partner with Manufacturing teams to prepare subject matter experts for regulatory inspections, internal audits, and quality reviews through coaching, mock interviews, and inspection readiness activities.

Evaluate audit observations, inspection feedback, and investigation trends to identify opportunities for strengthening investigation practices, quality systems, and inspection readiness.

Drive continuous improvements to investigation processes, quality systems, and inspection readiness programs.

Provide expert consultation and coaching on advanced root cause analysis methodologies.

Clearly communicate investigation progress, risks, and outcomes to impacted areas and senior leadership.

Coordinate and effectively lead cross-functional teams through high-impact investigations and complete milestones on schedule.

Present complex technical topics to leadership, auditors, and health authority inspectors.

Partner with Quality, Manufacturing, Engineering, Process Development, Automation, and corporate functions to strengthen quality culture and compliance.

Develop and maintain metrics to assess investigation effectiveness, CAPA effectiveness, and inspection readiness.

Mentor investigators and cross-functional teams on investigation excellence, technical writing, and regulatory expectations.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The collaborative investigator we seek has a biologics Drug Substance manufacturing and investigations background with strong cross-functional project management, regulatory presentation experience, and communication skills as well as the below qualifications.

Basic Qualifications:

Doctorate degree & 2 year of directly related experience

Master’s degree & 4 years of directly related experience

Bachelor’s degree or & 6 years of directly related experience

Associate’s degree & 10 years of directly related experience

High school diploma / GED & 12 years of directly related experience

Preferred Qualifications:

7+ years related work experience (manufacturing, microbiology, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility

Demonstrated expertise leading complex investigations and assessing investigation quality, technical rigor, and regulatory compliance.

Extensive experience with compliance, root cause analysis methodologies, quality risk management, CAPA effectiveness, and quality systems.

Degree in Science or Engineering.

Deep knowledge of FDA, EMA, and global GMP regulations, inspection expectations, and industry best practices related to investigation management and quality systems.

Demonstrated success serving as a technical SME during regulatory inspections, internal audits, and inspection readiness activities.

Experience using Veeva QMS for deviation investigations and CAPAs.

Strong project and program management skills.

Experience influencing senior leadership and driving site-wide quality initiatives.

Demonstrated ability to mentor and develop investigators and technical professionals.

Excellent written and verbal communication skills.

Experience reviewing, authoring, or coaching complex deviation investigations to ensure technical rigor, regulatory compliance, and inspection readiness.

Experience developing investigation narratives, storyboards, or technical presentations to effectively communicate quality events during audits and regulatory inspections.

Experience preparing manufacturing personnel and subject matter experts for regulatory inspections, internal audits, or management reviews.

Strong understanding of manufacturing operations, deviation management, CAPA systems, and inspection readiness principles.

Ability to work effectively in a matrix environment and build strong cross-functional relationships.

Thrive

What you can expect of us

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

Stock-based long-term incentives

Award-winning time-off plans and bi-annual company-wide shutdowns

Flexible work models, including remote work arrangements, where possible

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

#AmgenNorthCarolina

Apply Now

Refine Your Search

senior quality assurance inspector jobs in raleigh nc

Senior Specialist – Investigations & Regulatory Inspections

Senior Associate Manufacturing – Manufacturing Investigations

Associate Director, Quality Assurance - Regenerative Organ Manufacturing (RMOMAL)

Senior Specialist – Contamination Control and Investigations

Electrical Superintendent

Sr. Quality Specialist - cGMP Manufacturing - 12-Hr Night Shift 2-2-3

Senior Field Testing Technician

Director, Site Quality - Raleigh

Quality Director

QUALITY CONTROL MANAGER

NCDOT Transportation Construction Inspector (Levels 3 & 4) (Full-Time)

NCDOT Transportation Construction Inspector (Levels 1 & 2) (Full-Time)

Resident Project Representative - Water - Raleigh

Project Engineering Technician I - CQA

Project Engineering Tchnician I - CQA

More jobs to discover

Explore jobs in cities nearby

I want to receive the latest job alert for senior quality assurance inspector in raleigh nc

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected