Top 486 Regulatory specialist Jobs in Raleigh Nc

Manufacturing QA Specialist
Guerbet —Raleigh, NC
- Full-time
- Mid-level
- 3 years
- Warehouse
4d
Associate Clinical Director (BCBA)
Autism Learning Partners —Garner, NC
- From $105,000 a year
- Psychology
- Senior level
- Continuing education credits
- Mileage reimbursement
Quick Apply
Supplier Quality Specialist
Guerbet —Raleigh, NC
- Full-time
- Mid-level
- Contracts
- Radiology
Sr. EHS Specialist
Guerbet —Raleigh, NC
- Full-time
- Computer literacy
- Bachelor of Science
- Windows
3d
Pediatric Palliative Care Specialist- RN, Full-time
TRANSITIONS LIFECARE —Raleigh, NC
- Weekends as needed
- Spanish
- CPR Certification
- Nursing
Quick Apply
Clinical Nurse Leader - Cardiology Stepdown
Duke Health —Durham, NC
- Nights as needed
- Nursing
- RN License
- BLS Certification
- Relocation assistance
- Loan forgiveness
Cardiovascular Invasive Specialist Cardiac Catherization Lab
Duke Health —Durham, NC
- Full-time
- Laboratory
- BLS Certification
- Mid-level
- Relocation assistance
Nursing Professional Development Specialist, RN
WakeMed Health & Hospitals —Raleigh, NC
- Full-time
- Nursing
- RN License
- Hospital
Transitions to Community Living (TCL) Supervisor
Carolina Outreach —Raleigh, NC
- $57,806.91 - $77,904.14 a year
- Full-time
- Licensed Clinical Social Worker
- Mid-level
- Children
- Health savings account
- Disability insurance
Quick Apply
Supervisor, Sample Management
BioAgilytix —Durham, NC
- Weekends as needed
- Mid-level
- Office
- 3 years
- Health savings account
- Paid holidays
Quick Apply
8d
Physical Therapist - School Setting in Durham, NC
Soliant —Durham, NC
- Part-time
- School experience
- Classroom
- Physical & Rehabilitation Medicine
Quick Apply
14d
Cardiovascular Invasive Specialist Cardiac EP Lab
Duke Health —Durham, NC
- Full-time
- Laboratory
- Computer literacy
- BLS Certification
- Relocation assistance
9d
RSVP - W2 Life Insurance Specialist - Remote - Hiring Event
Insurance Supermarket Inc. —North Carolina
- $38,500 - $180,000 a year
- Full-time
- Computer literacy
- Mid-level
- Communication skills
- Health insurance
- Paid time off
12d
Private Client Banker - Brier Creek - Raleigh, NC
JPMorganChase —Raleigh, NC
- Weekends as needed
- Military
- Mid-level
- Office
- Health insurance
- Tuition reimbursement
2d
Foster Care Specialist
Methodist Home For Children —Raleigh, NC
- $45,000 - $48,000 a year
- Full-time
- Clean driving record
- Mid-level
- Driver's License
- 403(b) matching
- Health savings account
Quick Apply
Human Resource Specialist
Insperity Support Services, L.P. —Raleigh, NC
- Full-time
- Customer service
- Mid-level
- 3 years
- Health insurance
- Dental insurance
Clinical Nurse Leader (MIDS) - Emergency Department
Duke Health —Durham, NC
- Full-time
- Nursing
- RN License
- Computer literacy
- Opportunities for advancement
8d
Clinical Nurse Leader (NIGHTS) - Emergency Department
Duke Health —Durham, NC
- Full-time
- Nursing
- RN License
- Computer literacy
- Opportunities for advancement
QA Specialist (Hybrid)
Eisai —Raleigh, NC
- $66,200 - $86,800 a year
- Full-time
- Hybrid work
- Mid-level
- Bachelor's degree
- Continuous improvement
Hazardous Materials Call Center Support Specialist
3E —Raleigh, NC
- $40,000 - $50,000 a year
- Full-time
- Remote
- Microsoft Word
- Microsoft Excel
- Computer literacy
- Disability insurance
- Health insurance
Quick Apply
11d

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regulatory specialist jobs near raleigh nc

Manufacturing QA Specialist

Guerbet -
Raleigh, NC

Apply Now

Job Details

Full-time
4 days ago

Qualifications

Defect resolution root cause analysis
Preventive action implementation
Production deviation management
Quality control preventive actions
Corrective and preventive actions (CAPA)
Internal investigations
Manufacturing facility experience
Pharmaceutical company experience
Issue tracking
Quality assurance experience within pharmaceutical industry
Quality control experience within pharmaceutical industry
Productivity software
Visual inspection for quality control
Failure analysis

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 Manufacturing Quality Assurance Specialist will operate 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 Manufacturing Quality Assurance Specialist provides on-floor quality oversight across cGMP manufacturing operations, including formulation, filling, sterilization, packaging, and warehouse activities. The role ensures compliance with site SOPs and regulatory requirements through real time monitoring, review of critical process documentation, and verification of product and process controls. The position also supports sample inspections, responds to atypical quality events and nonconformance, facilitates containment and issue escalation, and partners with operations to ensure timely sampling, effective defect management, and continuous adherence to quality standards.

YOUR ROLE

Monitors compliance to meet or exceed site SOPs/cGMPs during production and warehouse operations.
Supports required QA inspections, i.e. Sample defect detection.
Ability to participate in internal audits, as requested.
Provides primary daily support to the production and warehouse area, up to and including tasks such as packaging line clearance verification, material segregation/containment, low product fill response, rework reconciliations/accountabilities, and documentation real time review.
Primary QA event response personnel that will respond to exceptions within the operations/packaging areas, having functions of initial exception impact assessment, product containment, bracketing, initial scope identification, and direction of immediate actions to take prior to resuming processing.
Assists personnel in the generation of operations/packaging area related exceptions.
Supports minor exceptions and phase II manufacturing investigations.
Attends daily operations staff communication meetings.
Team member of Facilities meetings regarding operations Preventive Maintenance/Calibration/Work Order status and scheduling.
Team members during area shutdown or maintenance projects as needed.
Assisting in punch list generation & verification, as well as area inspections pre/post activity.
Perform weekly walkthroughs of the operations/packaging area and communicate any observations to associated area management.
Ability to pass visual acuity exam for production and identification of quality product purposes.
Ability to support the batch release functions on an as needed basis.
Supports site and departmental initiatives.

YOUR BACKGROUND

Required Qualifications

Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline (e.g., Biology, Chemistry, Microbiology, Pharmaceutical Sciences) required.
3-6 years of experience in pharmaceutical manufacturing, quality assurance, or aseptic operations required.
Hands-on experience providing QA oversight on the manufacturing floor, including formulation, filling, sterilization, packaging, or warehouse GMP operations required.
Prior experience performing or verifying line clearances, room clearances, and/or batch record review required.
Familiarity with deviation management, root cause analysis, and execution of corrective and preventative actions (CAPA) required.
Skilled competency with computers, MS Office software required

Preferred Qualifications

Experience observing and evaluating aseptic behaviors, gowning qualification, environmental controls, and contamination control practices preferred.
ASQ inspection certification preferred.
Experience working with ISO, FDA, or EU Annex-1 regulated environments preferred.
Experience with pharmaceutical CAPA systems (e.g., Trackwise, Metric Stream, etc.)

Apply Now

Refine Your Search

regulatory specialist jobs in raleigh nc

Manufacturing QA Specialist

Associate Clinical Director (BCBA)

Supplier Quality Specialist

Sr. EHS Specialist

Pediatric Palliative Care Specialist- RN, Full-time

Clinical Nurse Leader - Cardiology Stepdown

Cardiovascular Invasive Specialist Cardiac Catherization Lab

Nursing Professional Development Specialist, RN

Transitions to Community Living (TCL) Supervisor

Supervisor, Sample Management

Physical Therapist - School Setting in Durham, NC

Cardiovascular Invasive Specialist Cardiac EP Lab

RSVP - W2 Life Insurance Specialist - Remote - Hiring Event

Private Client Banker - Brier Creek - Raleigh, NC

Foster Care Specialist

Human Resource Specialist

Clinical Nurse Leader (MIDS) - Emergency Department

Clinical Nurse Leader (NIGHTS) - Emergency Department

QA Specialist (Hybrid)

Hazardous Materials Call Center Support Specialist

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